Pain

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Treatment was attempted for both a suspected spider bite (2 weeks of topical triamcinolone 0.1%) and presumed cellulitis (oral doxycycline 100 mg bid/5 d), but neither improved her condition. Concerned for the possibility of cutaneous breast cancer, a punch biopsy was ordered and revealed diffuse dermal angiomatosis (DDA).

DDA is an uncommon proliferation of cutaneous blood vessels causing a reticular blood vessel pattern, as seen in this image. Typically, DDA is associated with tissue hypoxia due to arterial insufficiency from peripheral artery disease. In recent years, there have been numerous case reports of painful ulcerated lesions and reticular blood vessels occurring in women with large, pendulous breasts, increased body mass index, and a history of smoking. One theory suggests that the weight of the breasts causes tissue to stretch, compressing the blood vessels. This, combined with smoking, leads to localized hypoxia and DDA.

Treatments have included oral isotretinoin, calcium channel blockers, aspirin, or pentoxifylline to help circulation. Smoking cessation is recommended, as well as reduction mammoplasty to decrease the stretch on the tissues and relieve the local hypoxia. Although invasive, breast reduction surgery has moved to the forefront of therapy, with reports having shown resolution of the ulcers and pain.¹

Two important aspects of clinical medicine are highlighted by this case. First, nonhealing lesions that are not responding to prescribed therapies may require biopsy to rule out malignancy. Second, when there is difficulty making a diagnosis, especially with uncommon diseases, biopsy and input from a pathologist can be extremely helpful.

In this case, the patient was referred to Plastic Surgery and scheduled for reduction mammoplasty. The patient was advised to stop smoking for at least 4 weeks prior to the surgery to possibly improve her condition and reduce the likelihood of postoperative complications.

‌

Photo courtesy of Michael Louie, MD, and text courtesy of Michael Louie, MD, and Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

[email protected]

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

[email protected]

The Food and Drug Administration has warned two manufacturers about illegal marketing of drugs containing cannabidiol (CBD) for over-the-counter use without an approved new drug application, for using substandard manufacturing processes, and for failure to comply with current good manufacturing practices. These warnings add to 51 previous warning letters issued by the FDA since 2015 to other manufacturers of products containing CBD who were violating the Federal Food, Drug, and Cosmetic Act.

In a news release, the agency explained that its two most recent letters, sent to Honest Globe Inc. on March 15 and BioLyte Laboratories LLC on March 18, were issued because CBD has “known pharmacologic effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA.” They also describe the companies’ failures to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” FDA Principal Deputy Commissioner Amy P. Abernethy, MD, PhD, said in the release. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient [Epidiolex]. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”

The specific products from Santa Ana, Calif.–based Honest Globe that the FDA called unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act included Elixicure Original Pain Relief and Elixicure Lavender Pain Relief, both of which were described as containing CBD. Products from Grand Rapids, Mich.–based BioLyte Laboratories LLC that the FDA similarly cited for violations included Silver Gel, Silver Gel with Aloe, Silver Liquid Supplement, Therapeutic Pain Gel, Pain Relief Cream, and Magnesium Oil Spray.

The agency has asked the two companies to respond to its letters within 15 working days, “stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”

[email protected]

Older adults with chronic obstructive pulmonary disease who began using synthetic cannabinoids showed a 64% increase in all-cause mortality, compared with nonusers, findings from a large study have shown.

Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.

Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.

“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.

In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.

Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.

Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”


 

Dose makes a difference

All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
 

Potential limitations and implications

“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.

The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.

The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.

The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.

Older adults with chronic obstructive pulmonary disease who began using synthetic cannabinoids showed a 64% increase in all-cause mortality, compared with nonusers, findings from a large study have shown.

Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.

Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.

“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.

In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.

Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.

Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”


 

Dose makes a difference

All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
 

Potential limitations and implications

“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.

The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.

The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.

The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.

Older adults with chronic obstructive pulmonary disease who began using synthetic cannabinoids showed a 64% increase in all-cause mortality, compared with nonusers, findings from a large study have shown.

Synthetic cannabinoids drugs, such as nabilone and dronabinol, have been approved by the Food and Drug Administration for nausea and vomiting caused by chemotherapy. But their off-label use by adults with COPD to help manage chronic musculoskeletal pain, insomnia, and refractory dyspnea is on the rise, wrote Nicholas T. Vozoris, MD, of the University of Toronto and colleagues.

Cannabinoids may actually contribute to negative respiratory outcomes among individuals with COPD through several possible mechanisms including causing sedation, inducing anxiety, and provoking respiratory muscle weakness, they said.

“Possible adverse respiratory effects of cannabinoids may occur with greater likelihood among older adults (in whom COPD is more prevalent), as this group is known to less efficiently metabolise drugs,” they noted.

In a retrospective, population-based cohort study published in Thorax the researchers identified 185,876 adults aged 66 years and older with COPD using health administrative database information from 2006 to 2016. New cannabinoid users (those starting nabilone or dronabinol) were matched with control nonusers (defined as new users of noncannabinoid drugs). Individuals receiving palliative care, or having a diagnosis of cancer or HIV, were excluded because these are settings where synthetic cannabinoids may be prescribed for nausea or vomiting, and these patients are more likely to be in a poorer state of health.

Overall, new cannabinoid users had significantly higher all-cause mortality rates, compared with nonusers (hazard ratio, 1.64). The effects was greater in high-dose users.

Daniel R. Ouellette, MD, associate professor of medicine at Wayne State University and a senior staff physician at Henry Ford Hospital, both in Detroit, commented that this study has value for clinicians. “Many states are liberalizing cannabinoid use, and it is important to know the health effects of this type of drug on patients with chronic respiratory disease,” he noted. “The study is somewhat surprising. While one might have expected adverse consequences in patients with COPD who inhaled smoke from cannabinoids, it is somewhat unexpected that oral use would be associated with adverse consequences.” He added, “Pain in older adults is a complex problem. Cannabinoids are often recommended for pain in the general community, but pain per se is not a primary symptom for most patients with COPD from their respiratory problems. Physicians treating patients with COPD should diagnose the cause of the pain and provide appropriate treatment.”


 

Dose makes a difference

All-cause mortality increased by 231% and hospitalization for COPD or pneumonia increased by 178% among new users of higher-dose cannabinoids, compared with nonusers. Higher dose was defined in this study as more than 1.5mg/day of nabilone. No significant differences appeared in new users vs. nonusers in hospitalization for COPD or pneumonia at lower doses, and no significant differences appeared overall in outpatient respiratory exacerbations, emergency department visits for COPD or pneumonia, or COPD- or pneumonia-related mortality.
 

Potential limitations and implications

“The fact that COPD- or pneumonia-related mortality was not observed to occur with significantly greater rates among cannabinoid users with COPD may suggest that the increased all-cause mortality finding was not being driven by adverse respiratory-related drug effects, as we hypothesized, and instead was possibly a result of unresolved confounding,” the researchers noted.

The study findings were limited by several factors including the inability to prove causation in an observational study, and the potential for confounding based on unmeasured differences between cannabinoid users and nonusers, the researchers said. “Our findings may not be generalizable to all individuals with COPD, as our study included only those aged 66 years and older, and our COPD identification algorithm, while highly specific, had modest sensitivity,” they added. However, the results were strengthened by the large study population and suggest that cannabinoids are not contraindicated for older adults with COPD, the researchers said. “There can be legitimate reasons for using cannabinoids in this population, such as to help treat chemotherapy-related nausea and vomiting, and possibly for end-of-life care,” they emphasized.

The study findings serve to inform clinicians of the significantly increased mortality risk when older adults with COPD initiate cannabinoids, and “this information should be discussed with patients and incorporated in prescribing decision-making and management plans,” along with consideration of using lower doses when possible to minimize adverse events, they concluded.

The study was supported by The Lung Association – Ontario Grant Review/Grant-In-Aid. The researchers had no financial conflicts to disclose.

In the January 2019 article “Migraine: Expanding our Tx arsenal” (J Fam Pract. 2019;68:10-14,16-24), Table 2: Establishing the differential diagnosis of headache provided information that was incorrectly categorized. The table should not have included “Temporal arteritis” as a trigger for a headache caused by infection. Rather, the table should have listed “Temporal arteritis” among the triggers for a headache caused by an autoimmune disorder. In addition, “Acute and chronic sinusitis” and “Meningitis” should not have been listed as triggers for a headache with an iatrogenic or intoxication cause. Rather, they should have been the only triggers attributed to headaches with an infectious origin. The revised table can be found here.

In the January 2019 article “Migraine: Expanding our Tx arsenal” (J Fam Pract. 2019;68:10-14,16-24), Table 2: Establishing the differential diagnosis of headache provided information that was incorrectly categorized. The table should not have included “Temporal arteritis” as a trigger for a headache caused by infection. Rather, the table should have listed “Temporal arteritis” among the triggers for a headache caused by an autoimmune disorder. In addition, “Acute and chronic sinusitis” and “Meningitis” should not have been listed as triggers for a headache with an iatrogenic or intoxication cause. Rather, they should have been the only triggers attributed to headaches with an infectious origin. The revised table can be found here.

In the January 2019 article “Migraine: Expanding our Tx arsenal” (J Fam Pract. 2019;68:10-14,16-24), Table 2: Establishing the differential diagnosis of headache provided information that was incorrectly categorized. The table should not have included “Temporal arteritis” as a trigger for a headache caused by infection. Rather, the table should have listed “Temporal arteritis” among the triggers for a headache caused by an autoimmune disorder. In addition, “Acute and chronic sinusitis” and “Meningitis” should not have been listed as triggers for a headache with an iatrogenic or intoxication cause. Rather, they should have been the only triggers attributed to headaches with an infectious origin. The revised table can be found here.

Nearly one-third of persons with hemophilia had neuropathic pain or altered central pain mechanisms, investigators in a small study found.

Among 30 patients with hemophilia, 9 (30%) had scores of 4 or greater on the 10-point Diabetic Neuropathy 4 (DN4) scale, indicating significant neuropathic pain, reported Nathalie Roussel, PhD, from the University of Antwerp (Belgium), at the annual congress of the European Association for Haemophilia and Allied Disorders.

“The results of this study show us that a large difference exists in pain assessments when we have consecutive sample of patients with hemophilia. These results also show that there are subgroups of patients with altered central pain mechanisms and other subgroups with neuropathic pain, and patients with neuropathic pain have a significantly worse quality of life that is not associated with joint structure and joint function,” she said.

“This is a very good abstract in my opinion, and it deserves more study,” commented hemophilia specialist Rajiv K. Pruthi, MBBS, from the Mayo Clinic in Rochester, Minn., who was not involved in the study.

Structural and functional tests

To get a better understanding of the complexities of ankle pain in persons with hemophilia, Dr. Roussel and colleagues recruited 30 adults followed at their center for moderate or severe hemophilia A or B who were on replacement therapy with factor VIII or factor IX concentrate.

They used MRI without contrast to look for structural alterations in both the talocrural and subtalar joints of both ankles in all patients using the International Prophylaxis Study Group Score, adapted for subtalar joint assessment.

The investigators also used the hemophilia joint health score to assess joint funding, and tests for limits on physical activity, including the Timed Up and Go Test, 2-minute walk test, and Hemophilia Activities Lists.

In addition, they assessed pain with Quantitative Sensory Testing, a noninvasive method for evaluating patient responses to heat, cold, and mechanical pressure. Other measures included questionnaires regarding neuropathic pain and quality of life.

The participants included 23 patients with severe and 3 with moderate hemophilia A, and 1 patient with severe and 3 with moderate hemophilia B. The mean patient age was 39.4 years.

In all, 24 of the 30 patients (80%) were on prophylaxis, and 9 (30%) reported using pain medications; 25 patients reported having some degree of pain.

On MRI, 48/60 (80%) of talocrural joints imaged had pathological findings, as did 41 of 60 (68%) subtalar joints.

“Despite the fact that these patients do not all suffer from ankle joint pain, a lot of them have signs of joint pathology,” Dr. Roussel said.

On the Brief Pain Inventory, only 5 patients had no reported pain, but 14 patients reported either three, five, or six painful locations, and 20 out of 30 patients reported that their ankles were the most affected joints.

Although the sample size was not large enough for statistical comparisons, there were also large variations in pain perception across hemophilia severity.

“This is an important finding, that also patients with moderate hemophilia can have intense pain,” Dr. Roussel said.

On the DN4 questionnaire, nine patients had scores of 4 or greater, indicating that their pain was neuropathic in origin.

When they compared the patients with neuropathic pain with those suffering from nonneuropathic pain, the investigators observed similar structural and joint function between the groups, but significantly worse reported quality of life for patients with neuropathic pain.

“This is a finding that merits further attention,” she commented.

In correlation analyses, the investigators also found that MRI scores did not correlate significantly with either hemophilia joint health score, physical function, participation in activities, or pressure pain thresholds.
 

Why the discrepancies?

Dr. Pruthi said in an interview that he has seen evidence from other studies showing that some patients with hemophilia who were on prophylaxis had MRI evidence of joint damage, while others who used on-demand therapy had none.

“That opens up a whole can of worms as to what are we dealing with here. Why do some patients end up with damage and others don’t?” he asked.

He said that the finding that the origin of pain in a large proportion of patients was neuropathic rather than arthritic in origin was new to him.

“It raises a lot of good questions: maybe we need to be managing pain in these patients with nonnarcotic approaches, and in this day and age with the opioid crisis it’s even more important to do that,” he said.

He hypothesized that degenerative arthritis may irritate nearby nerves, resulting in neuropathic pain.

The study was funded by EAHAD, with support from participating institutions. Dr. Roussel and Dr. Pruthi reported no conflicts of interest to declare.

Nearly one-third of persons with hemophilia had neuropathic pain or altered central pain mechanisms, investigators in a small study found.

Among 30 patients with hemophilia, 9 (30%) had scores of 4 or greater on the 10-point Diabetic Neuropathy 4 (DN4) scale, indicating significant neuropathic pain, reported Nathalie Roussel, PhD, from the University of Antwerp (Belgium), at the annual congress of the European Association for Haemophilia and Allied Disorders.

“The results of this study show us that a large difference exists in pain assessments when we have consecutive sample of patients with hemophilia. These results also show that there are subgroups of patients with altered central pain mechanisms and other subgroups with neuropathic pain, and patients with neuropathic pain have a significantly worse quality of life that is not associated with joint structure and joint function,” she said.

“This is a very good abstract in my opinion, and it deserves more study,” commented hemophilia specialist Rajiv K. Pruthi, MBBS, from the Mayo Clinic in Rochester, Minn., who was not involved in the study.

Structural and functional tests

To get a better understanding of the complexities of ankle pain in persons with hemophilia, Dr. Roussel and colleagues recruited 30 adults followed at their center for moderate or severe hemophilia A or B who were on replacement therapy with factor VIII or factor IX concentrate.

They used MRI without contrast to look for structural alterations in both the talocrural and subtalar joints of both ankles in all patients using the International Prophylaxis Study Group Score, adapted for subtalar joint assessment.

The investigators also used the hemophilia joint health score to assess joint funding, and tests for limits on physical activity, including the Timed Up and Go Test, 2-minute walk test, and Hemophilia Activities Lists.

In addition, they assessed pain with Quantitative Sensory Testing, a noninvasive method for evaluating patient responses to heat, cold, and mechanical pressure. Other measures included questionnaires regarding neuropathic pain and quality of life.

The participants included 23 patients with severe and 3 with moderate hemophilia A, and 1 patient with severe and 3 with moderate hemophilia B. The mean patient age was 39.4 years.

In all, 24 of the 30 patients (80%) were on prophylaxis, and 9 (30%) reported using pain medications; 25 patients reported having some degree of pain.

On MRI, 48/60 (80%) of talocrural joints imaged had pathological findings, as did 41 of 60 (68%) subtalar joints.

“Despite the fact that these patients do not all suffer from ankle joint pain, a lot of them have signs of joint pathology,” Dr. Roussel said.

On the Brief Pain Inventory, only 5 patients had no reported pain, but 14 patients reported either three, five, or six painful locations, and 20 out of 30 patients reported that their ankles were the most affected joints.

Although the sample size was not large enough for statistical comparisons, there were also large variations in pain perception across hemophilia severity.

“This is an important finding, that also patients with moderate hemophilia can have intense pain,” Dr. Roussel said.

On the DN4 questionnaire, nine patients had scores of 4 or greater, indicating that their pain was neuropathic in origin.

When they compared the patients with neuropathic pain with those suffering from nonneuropathic pain, the investigators observed similar structural and joint function between the groups, but significantly worse reported quality of life for patients with neuropathic pain.

“This is a finding that merits further attention,” she commented.

In correlation analyses, the investigators also found that MRI scores did not correlate significantly with either hemophilia joint health score, physical function, participation in activities, or pressure pain thresholds.
 

Why the discrepancies?

Dr. Pruthi said in an interview that he has seen evidence from other studies showing that some patients with hemophilia who were on prophylaxis had MRI evidence of joint damage, while others who used on-demand therapy had none.

“That opens up a whole can of worms as to what are we dealing with here. Why do some patients end up with damage and others don’t?” he asked.

He said that the finding that the origin of pain in a large proportion of patients was neuropathic rather than arthritic in origin was new to him.

“It raises a lot of good questions: maybe we need to be managing pain in these patients with nonnarcotic approaches, and in this day and age with the opioid crisis it’s even more important to do that,” he said.

He hypothesized that degenerative arthritis may irritate nearby nerves, resulting in neuropathic pain.

The study was funded by EAHAD, with support from participating institutions. Dr. Roussel and Dr. Pruthi reported no conflicts of interest to declare.

Nearly one-third of persons with hemophilia had neuropathic pain or altered central pain mechanisms, investigators in a small study found.

Among 30 patients with hemophilia, 9 (30%) had scores of 4 or greater on the 10-point Diabetic Neuropathy 4 (DN4) scale, indicating significant neuropathic pain, reported Nathalie Roussel, PhD, from the University of Antwerp (Belgium), at the annual congress of the European Association for Haemophilia and Allied Disorders.

“The results of this study show us that a large difference exists in pain assessments when we have consecutive sample of patients with hemophilia. These results also show that there are subgroups of patients with altered central pain mechanisms and other subgroups with neuropathic pain, and patients with neuropathic pain have a significantly worse quality of life that is not associated with joint structure and joint function,” she said.

“This is a very good abstract in my opinion, and it deserves more study,” commented hemophilia specialist Rajiv K. Pruthi, MBBS, from the Mayo Clinic in Rochester, Minn., who was not involved in the study.

Structural and functional tests

To get a better understanding of the complexities of ankle pain in persons with hemophilia, Dr. Roussel and colleagues recruited 30 adults followed at their center for moderate or severe hemophilia A or B who were on replacement therapy with factor VIII or factor IX concentrate.

They used MRI without contrast to look for structural alterations in both the talocrural and subtalar joints of both ankles in all patients using the International Prophylaxis Study Group Score, adapted for subtalar joint assessment.

The investigators also used the hemophilia joint health score to assess joint funding, and tests for limits on physical activity, including the Timed Up and Go Test, 2-minute walk test, and Hemophilia Activities Lists.

In addition, they assessed pain with Quantitative Sensory Testing, a noninvasive method for evaluating patient responses to heat, cold, and mechanical pressure. Other measures included questionnaires regarding neuropathic pain and quality of life.

The participants included 23 patients with severe and 3 with moderate hemophilia A, and 1 patient with severe and 3 with moderate hemophilia B. The mean patient age was 39.4 years.

In all, 24 of the 30 patients (80%) were on prophylaxis, and 9 (30%) reported using pain medications; 25 patients reported having some degree of pain.

On MRI, 48/60 (80%) of talocrural joints imaged had pathological findings, as did 41 of 60 (68%) subtalar joints.

“Despite the fact that these patients do not all suffer from ankle joint pain, a lot of them have signs of joint pathology,” Dr. Roussel said.

On the Brief Pain Inventory, only 5 patients had no reported pain, but 14 patients reported either three, five, or six painful locations, and 20 out of 30 patients reported that their ankles were the most affected joints.

Although the sample size was not large enough for statistical comparisons, there were also large variations in pain perception across hemophilia severity.

“This is an important finding, that also patients with moderate hemophilia can have intense pain,” Dr. Roussel said.

On the DN4 questionnaire, nine patients had scores of 4 or greater, indicating that their pain was neuropathic in origin.

When they compared the patients with neuropathic pain with those suffering from nonneuropathic pain, the investigators observed similar structural and joint function between the groups, but significantly worse reported quality of life for patients with neuropathic pain.

“This is a finding that merits further attention,” she commented.

In correlation analyses, the investigators also found that MRI scores did not correlate significantly with either hemophilia joint health score, physical function, participation in activities, or pressure pain thresholds.
 

Why the discrepancies?

Dr. Pruthi said in an interview that he has seen evidence from other studies showing that some patients with hemophilia who were on prophylaxis had MRI evidence of joint damage, while others who used on-demand therapy had none.

“That opens up a whole can of worms as to what are we dealing with here. Why do some patients end up with damage and others don’t?” he asked.

He said that the finding that the origin of pain in a large proportion of patients was neuropathic rather than arthritic in origin was new to him.

“It raises a lot of good questions: maybe we need to be managing pain in these patients with nonnarcotic approaches, and in this day and age with the opioid crisis it’s even more important to do that,” he said.

He hypothesized that degenerative arthritis may irritate nearby nerves, resulting in neuropathic pain.

The study was funded by EAHAD, with support from participating institutions. Dr. Roussel and Dr. Pruthi reported no conflicts of interest to declare.

Veterans with upper limb amputation (ULA) are a small, but important population, who have received more attention in the past decade due to the increased growth of the population of veterans with conflict-related amputation from recent military engagements. Among the 808 veterans with ULA receiving any care in the US Department of Veterans Affairs (VA) from 2010 to 2015 who participated in our national study, an estimated 28 to 35% had a conflict-related amputation.¹ The care of these individuals with ULA is highly specialized, and there is a recognized shortage of experienced professionals in this area.^2,3 The provision of high-quality prosthetic care is increasingly complex with advances in technology, such as externally powered devices with multiple functions.

The VA is a comprehensive, integrated health care system that serves more than 8.9 million veterans each year. Interdisciplinary amputation care is provided within the VA through a traditional clinic setting or by using one of several currently available virtual care modalities.^4,5 In consultation with the veteran, VA health care providers (HCPs) prescribe prostheses and services based on the clinical needs and furnish authorized items and services to eligible veterans. Prescribed items and/or services are furnished either by internal VA resources or through a community-based prosthetist who is an authorized vendor or contractor. Although several studies have reported that the majority of veterans with ULA utilize VA services for at least some aspects of their health care, little is known about: (1) prosthetic limb care satisfaction or the quality of care that veterans receive; or (2) how care within the VA or Department of Defense (DoD) compares with care provided in the civilian sector.^6-8

Earlier studies that examined the amputation rehabilitation services received by veterans with ULA pointed to quality gaps in care and differences in satisfaction in the VA and DoD when compared with the civilian sector but were limited in their scope and methodology.^7,8 A 2008 study of veterans of the Vietnam War, Operation Iraqi Freedom (OIF), and Operation Enduring Freedom (OEF) compared satisfaction by location of care receipt (DoD only, VA only, private only, and multiple sources). That study dichotomized response categories for items related to satisfaction with care (satisfied/not), but did not estimate degree of satisfaction, calculate summary scores of the items, or utilize validated care satisfaction metrics. That study found that a greater proportion of Vietnam War veterans (compared with OIF/OEF veterans receiving care in the private sector) agreed that they “had a role in choosing prosthesis” and disagreed that they wanted to change their current prosthesis to another type.⁷ The assumption made by the authors is that much of this private sector care was actually VA-sponsored care prescribed and procured by the VA but delivered in the community. However, no data were collected to confirm or refute this assumption, and it is possible that some care was both VA sponsored and delivered, some was VA sponsored but commercially delivered, and in some cases, care was sponsored by other sources and delivered in still other facilities.

A 2012 VA Office of the Inspector General study of OIF, OEF, and Operation New Dawn (OND) veterans reported lower prosthetic satisfaction for veterans with upper limb when compared with lower limb amputation and described respondents concerns about lack of VA prosthetic expertise, difficulty with accessing VA services, and dissatisfaction with the sometimes lengthy approval process for obtaining fee-basis or VA contract care.⁸ Although this report suggested that there were quality gaps and areas for improvement, it did not employ validated metrics of prosthesis or care satisfaction and instead relied on qualitative data collected through telephone interviews.

Given the VA effort to enhance the quality and consistency of its amputation care services through the formal establishment of the Amputation System of Care, which began in 2008, further evaluation of care satisfaction and quality of care is warranted. In 2014 the VA and DoD released the first evidence-based clinical practice guidelines (CPGs) for the rehabilitation of persons with ULA.² The CPG describes care paths to improve outcomes and basic tenets of amputation rehabilitation care and can be used to identify process activities that are essential aspects of quality care. However, the extent to which the CPG has impacted the quality and timeliness of care for veterans with ULA are presently unclear.

Thus, the purposes of this study were to: (1) measure veteran satisfaction with prosthetic limb care and identify factors associated with service satisfaction; (2) assess quality indicators that potentially reflect CPG) adoption; (3) compare care satisfaction and quality for those who received care in or outside of the VA or DoD; and (4) evaluate change in satisfaction over time.

Methods

The study was approved by the VA Central Institutional Review Board (IRB) (Study #16-20) and Human Research Protection Office, U.S. Army Medical Research and Development Command. The sampling frame consisted of veterans with major ULA who received care in the VA between 2010 and 2015 identified in VA Corporate Data Warehouse. We sent recruitment packages to nondeceased veterans who had current addresses and phone numbers. Those who did not opt out or inform us that they did not meet eligibility criteria were contacted by study interviewers. A waiver of documentation of written informed consent was obtained from the VA Central IRB. When reached by the study interviewer, Veterans provided oral informed consent. At baseline, 808 veterans were interviewed for a response rate of 47.7% as calculated by the American Association for Public Opinion Research (AAPOR) methodology.⁹ Follow-up interviews approximately 1 year later (mean [SD] 367 [16.8] days), were conducted with 585 respondents for a 72.4% response rate (Figure).

Survey Content

Development and pilot testing of the survey instrument previously was reported.¹ The content of the survey drew from existing survey items and metrics, and included new items specifically designed to address patterns of amputation care, based on care goals within the CPG. All new and modified items were tested and refined through cognitive interviews with 10 participants, and tested with an additional 13 participants.

The survey collected data on demographics, amputation characteristics (year of amputation, level, laterality, and etiology), current prosthesis use, and type of prosthesis. This article focused on the sections of the survey pertaining to satisfaction with prosthetic care and indicators of quality of care. A description of the content of the full survey and a synopsis of overall findings are reported in a prior publication.¹ The key independent, dependent, and other variables utilized in the analyses reported in this manuscript are described below.

Primary Independent Variables

In the follow-up survey, we asked respondents whether they had any amputation care in the prior 12 months, and if so to indicate where they had gone for care. We categorized respondents as having received VA/DoD care if they reported any care at the VA or DoD, and as having received non-VA/DoD care if they did not report care at the VA or DoD but indicated that they had received amputation care between baseline and follow-up.

Two primary outcomes were utilized; the Orthotics and Prosthetics User’s Survey (OPUS), client satisfaction with services scale (CSS), and a measure of care quality specifically developed for this study. The CSS is a measure developed specifically for orthotic and prosthesis users.¹⁰ This 11-item scale measures satisfaction with prosthetic limb services and contains items evaluating facets of care such as courtesy received from prosthetists and clinical staff, care coordination, appointment wait time, willingness of the prosthetist to listen to participant concerns, and satisfaction with prosthesis training. Items are rated on a 4-point scale (strongly agree [1] to strongly disagree [4]), thus higher CSS scores indicate worse satisfaction with services. The CSS was administered only to prosthesis users.

The Quality of Care assessment developed for this study contained items pertaining to amputation related care receipt and care quality. These items were generated by the study team in consultation with representatives from the VA/DoD Extremity Amputation Center of Excellence after review of the ULA rehabilitation CPG. Survey questions asked respondents about the clinicians visited for amputation related care in the past 12 months, whether they had an annual amputation-related checkup, whether any clinician had assessed their function, worked with them to identify goals, and/or to develop an amputation-related care plan. Respondents were also asked whether there had been family/caregiver involvement in their care and care coordination, whether a peer visitor was involved in their initial care, whether they had received information about amputation management in the prior year, and whether they had amputation-related pain. Those that indicated that they had amputation-related pain were subsequently asked whether their pain was well managed, whether they used medication for pain management, and whether they used any nonpharmaceutical strategies.

Quality of Care Index

We initially developed 15 indicator items of quality of care. We selected 7 of the items to create a summary index. We omitted 3 items about pain management, since these items were completed only by participants who indicated that they had experienced pain; however, we examined the 3 pain items individually given the importance of this topic. We omitted an additional 2 items from the summary index because they would not be sensitive to change because they pertained to the care in the year after initial amputation. One of these items asked whether caregivers were involved in initial amputation management and the other asked whether a peer visit occurred after amputation. Another 3 items were omitted because they only were completed by small subsamples due to intentional skip patterns in the survey. These items addressed whether clinical HCPs discussed amputation care goals in the prior year, worked to develop a care plan in the prior year, or helped to coordinate care after a move. Completion rates for all items considered for the index are shown in eAppendix 1 (Available at doi:10.12788/fp.0096). After item selection, we generated an index score, which was the number of reported “yes” responses to the seven relevant items.

Other Variables

We created a single variable called level/laterality which categorized ULA as unilateral or bilateral. We further categorized respondents with unilateral amputation by their amputation level. We categorized respondents as transradial for wrist joint or below the elbow amputations; transhumeral for at or above the elbow amputations; and shoulder for shoulder joint or forequarter amputations. Participants indicated the amputation etiology using 7 yes/no variables: combat injury, accident, burn, cancer, diabetes mellitus, and infection. Participants could select ≥ 1 etiology.

Primary prosthesis type was categorized as body powered, myoelectric/hybrid, cosmetic, other/unknown, or nonuser. The service era was classified based on amputation date as Before Vietnam, Vietnam War, After Vietnam to Gulf War, After Gulf War to September 10, 2001, and September 11, 2001 to present. For race, individuals with > 1 race were classified as other. We classified participants by region, using the station identification of the most recent VA medical center that they had visited between January 1, 2010 and December 30, 2015.

The survey also employed 2 measures of satisfaction with the prosthesis, the Trinity Amputation and Prosthetic Experience Scale (TAPES) satisfaction scale and the OPUS Client Satisfaction with Devices (CSD). TAPES consists of 10 items addressing color, shape, noise, appearance, weight, usefulness, reliability, fit, comfort and overall satisfaction.¹¹ Items are rated on a 5-point Likert scale from very dissatisfied (1) to very satisfied (5). An 8-item version of the CSD scale was created for this study, after conducting a Rasch analysis (using Winsteps version 4.4.2) of the original 11-item CSD. The 8 items assess satisfaction with prosthesis fit, weight, comfort, donning ease, appearance, durability, skin contact, and pain. Items are rated on a 4-point scale from strongly agree (1) to strongly disagree (4); higher CSD scores indicate less satisfaction with devices. Psychometric analysis of the revised CSD score was reported in a prior publication.¹² We also reported on the CSS using the original 10-item measure.

Data Analyses

We described characteristics of respondents at baseline and follow-up. We used baseline data to calculate CSS scores and described scores for all participants, for subgroups of unilateral and bilateral amputees, and for unilateral amputees stratified by amputation level. Wilcoxon rank sum tests were used to compare the CSS item and total scores of 461 prosthesis users with unilateral amputation and 29 with bilateral amputation. To identify factors that we hypothesized might be associated with CSS scores at baseline, we developed separate bivariate linear regression models. We added those factors that were associated with CSS scores at P ≤ .1 in bivariate analyses to a multivariable linear regression model of factors associated with CSS score. The P ≤ .1 threshold was used to ensure that relevant confounders were controlled for in regression models. We excluded 309 participants with no reported prosthesis use (who were not asked to complete the CSS), 20 participants with other/unknown prosthesis types, and 106 with missing data on amputation care in the prior year or on satisfaction metrics. We used baseline data for this analysis to maximize the sample size.

We compared CSS scores for those who reported receiving care within or outside of the VA or DoD in the prior year, using Wilcoxon Mann-Whitney rank tests. We also compared scores of individual quality of care items for these groups using Fisher exact tests. We chose to examine individual items rather than the full Index because several items specified care receipt within the VA and thus would be inappropriate to utilize in comparisons by site location; however, we described responses to all items. In these analyses, we excluded 2 respondents who had conflicting information regarding location of care. We used follow-up data for this analysis because it allowed us to identify location of care received in the prior year.

We also described the CSS scores, the 7-item Quality of Care Index and responses to other items related to quality of care at baseline and follow-up. To examine whether satisfaction with prosthetic care or aspects of care quality had changed over time, we compared baseline and follow-up CSS and quality of care scores for respondents who had measures at both times using Wilcoxon signed ranks tests. Individual items were compared using McNemar tests.

Results

Respondents were 97.4% male and included 776 unilateral amputees and 32 bilateral amputees with a mean (SD) age of 63.3 (14.1) years (Table 1). Respondents had lost their limbs a mean (SD) 31.4 (14.1) years prior, and half were transradial, 34.2% transhumeral, and 11.6% shoulder amputation. At baseline 185 (22.9%) participants received amputation-related care in the prior year and 118 (20.2%) participants received amputation-related care within 1 year of follow-up. Of respondents, 113 (19.3%) stated that their care was between baseline and follow-up and 89 (78.8%) of these received care at either the VA, the DoD or both; just 16 (14.2%) received care elsewhere.

Mean (SD) CSS scores were highest (lower satisfaction) for those with amputation at the shoulder and lowest for those with transhumeral amputation: 42.2 (20.0) vs 33.4 (20.8). Persons with bilateral amputation were less satisfied in almost every category when compared with those with unilateral amputation, although the total CSS score was not substantially different. Wilcoxon rank sum analyses revealed statistically significant differences in wait time satisfaction: bilateral amputees were less satisfied than unilateral amputees. Factors associated with overall CSS score in bivariate analyses were CSD score, TAPES score, amputation care receipt, prosthesis type, race, and region of care (eAppendix 2, available at doi:10.12788/fp.0096).

Discussion

Our longitudinal study provides insights into the experiences of veterans with major ULA related to satisfaction with prosthetic limb care services and receipt of amputation-related care. We reported on the development and use of a new summary measure of amputation care quality, which we designed to capture some of the key elements of care quality as provided in the VA/DoD CPG.²

We used baseline data to identify factors independently associated with prosthetic limb care satisfaction as measured by a previously validated measure, the OPUS CSS. The CSS addresses satisfaction with prosthetic limb services and does not reflect satisfaction with other amputation care services. We found that persons who received amputation care in the prior year had CSS scores that were a mean 5.1 points better than those who had not received recent care. Although causality cannot be determined with this investigation, this finding highlights an important relationship between frequency of care and satisfaction, which can be leveraged by the VA in future care initiatives. Care satisfaction was also better by 0.7 points for every 1-point decrease (indicating higher satisfaction) in the OPUS CSD prosthetic satisfaction scale. This finding isn’t surprising, given that a major purpose of prosthetic limb care services is to procure and fit a satisfactory device. To determine whether these same relationships were observed in the smaller, longitudinal cohort data at follow-up, we repeated these models and found similar relationships between recent care receipt and prosthesis satisfaction and satisfaction with services. We believe that these findings are meaningful and emphasize the importance of both service and device satisfaction to the veteran with an ULA. Lower service satisfaction scores among those with amputations at the shoulder and those with bilateral limb loss suggest that these individuals may benefit from different service delivery approaches.

We did observe a difference in satisfaction scores by geographic region in the follow-up (but not the baseline) data with satisfaction higher in the Western vs the Southern region (data not shown). This finding suggests a need for continued monitoring of care satisfaction over time to determine whether differences by region persist. We grouped respondents into geographic region based on the location where they had received their most recent VA care of any type. Many veterans receive care at multiple VA locations. Thus, it is possible that some veterans received their amputation care at a non-VA facility or a VA facility in a different region.

Our findings related to prosthetic limb care services satisfaction are generalizable to veteran prosthesis users. Findings may not be generalizable to nonusers, because in our study, the CSS only was administered to prosthesis users. Thus, we were unable to identify factors associated with care satisfaction for persons who were not current users of an upper limb prosthesis.

The study findings confirmed that most veterans with ULA receive amputation-related care in the VA or DoD. We compared CSS and Quality of Care item scores for those who reported receiving care at the VA or DoD vs elsewhere. Amputation care within the VA is complex. Some services are provided at VA facilities and some are ordered by VA clinicians but provided by community-based HCPs. However, we found that better (though not statistically significantly different) CSS scores and several Quality of Care items were endorsed by a significantly more of those reporting care in the VA or DoD as compared to elsewhere. Given the dissemination of a rehabilitation of upper limb amputees CPG, we hypothesized that VA and DoD HCPs would be more aware of care guidelines and would provide better care. Overall, our findings supported this hypothesis while also suggesting that areas such as caregiver involvement and peer visitation may benefit from additional attention and program improvement.

We used longitudinal data to describe and compare CSS and Quality of Care Index scores. Our analyses did not detect any statistically significant differences between baseline and follow-up. This finding may reflect that this was a relatively stable population with regard to amputation experiences given the mean time since amputation was 31.4 years. However, we also recognize that our measures may not have captured all aspects of care satisfaction or quality. It is possible that there were other changes that had occurred over the course of the year that were not captured by the CSS or by the Quality of Care Index. It is also possible that some implementation and adoption of the CPG had happened prior to our baseline survey. Finally, it is possible that some elements of the CPG have not yet been fully integrated into clinical care. We believe that the latter is likely, given that nearly 80% of respondents did not report receiving any amputation care within the past year at follow-up, though the CPGs recommend an annual visit.

Aside from recall bias, 2 explanations must be considered relative to the low rate of adherence to the CPG recommendation for an annual follow-up. The first is that the CPG simply may not be widely adopted. The second is that the majority of patients with ULA who use prostheses use a body-powered system. These tend to be low maintenance, long-lasting systems and may ultimately not need annual maintenance and repair. Further, if the veteran’s body-powered system is functioning properly and health status has not changed, they may simply be opting out of an annual visit despite the CPG recommendation. Nonetheless, this apparent low rate of annual follow-up emphasizes the need for additional process improvement measures for the VA.

Strengths and Limitations

The VA provides a unique setting for a nationally representative study of amputation rehabilitation because it has centralized data sources that can be used to identify veterans with ULA. Our study had a strong response rate, and its prosthetic limb care satisfaction findings are generalizable to all veterans with major ULA who received VA care from 2010 to 2015. However, there are limits to generalizability outside of this population to civilians or to veterans who do not receive VA care. To examine possible nonresponse bias, which could limit generalizability, we compared the baseline characteristics of respondents and nonrespondents to the follow-up study (eAppendix 4 available at doi:10.12788/fp.0096). There were no significant differences in satisfaction, quality of care, or receipt of amputation-related care between those lost to follow-up and those with follow-up data. Although, we did find small differences in gender, race, and service era (defined by amputation date). We do not believe that these differences threaten the interpretation of findings at follow-up, but there may be limits to generalizability of these findings to the full baseline sample. The data were from a telephone survey of veterans. It is possible that some veterans did not recall their care receipt or did not understand some of the questions and thus may not have accurately answered questions related to type of care received or the timing of that care.

Our interpretation of findings comparing care received within the VA and DoD or elsewhere is also limited because we cannot say with certainty whether those who indicated no care in the VA or DoD actually had care that was sponsored by the VA or DoD as contract or fee-basis care. Just 8 respondents indicated that they had received care only outside of the VA or DoD in the prior year. There were also some limitations in the collection of data about care location. We asked about receipt of amputation care in the prior year and about location of any amputation care received between baseline and follow-up, and there were differences in responses. Thus, we used a combination of these items to identify location of care received in the prior year.

Despite these limitations, we believe that our study provides novel, important findings about the satisfaction with prosthetic limb care services and quality of amputation rehabilitation care for veterans. Findings from this study can be used to address amputation and prosthetic limb care satisfaction and quality weaknesses highlighted and to benchmark care satisfaction and CPG compliance. Other studies evaluating care guideline compliance have used indicators obtained from clinical records or data repositories.^13-15 Future work could combine self-reported satisfaction and care quality measures with indicators obtained from clinical or repository sources to provide a more complete snapshot of care delivery.

Conclusions

We reported on a national survey of veterans with major upper limb loss that assessed satisfaction with prosthetic limb care services and quality of amputation care. Satisfaction with prosthetic limb care was independently associated with satisfaction with the prosthesis, and receipt of care within the prior year. Most of the veterans surveyed received care within the VA or DoD and reported receiving higher quality of care, when compared with those who received care outside of the VA or DoD. Satisfaction with care and quality of care were stable over the year of this study. Data presented in this study can serve to direct VA amputation care process improvement initiatives as benchmarks for future work. Future studies are needed to track satisfaction with and quality of care for veterans with ULA.

Veterans with upper limb amputation (ULA) are a small, but important population, who have received more attention in the past decade due to the increased growth of the population of veterans with conflict-related amputation from recent military engagements. Among the 808 veterans with ULA receiving any care in the US Department of Veterans Affairs (VA) from 2010 to 2015 who participated in our national study, an estimated 28 to 35% had a conflict-related amputation.¹ The care of these individuals with ULA is highly specialized, and there is a recognized shortage of experienced professionals in this area.^2,3 The provision of high-quality prosthetic care is increasingly complex with advances in technology, such as externally powered devices with multiple functions.

The VA is a comprehensive, integrated health care system that serves more than 8.9 million veterans each year. Interdisciplinary amputation care is provided within the VA through a traditional clinic setting or by using one of several currently available virtual care modalities.^4,5 In consultation with the veteran, VA health care providers (HCPs) prescribe prostheses and services based on the clinical needs and furnish authorized items and services to eligible veterans. Prescribed items and/or services are furnished either by internal VA resources or through a community-based prosthetist who is an authorized vendor or contractor. Although several studies have reported that the majority of veterans with ULA utilize VA services for at least some aspects of their health care, little is known about: (1) prosthetic limb care satisfaction or the quality of care that veterans receive; or (2) how care within the VA or Department of Defense (DoD) compares with care provided in the civilian sector.^6-8

Earlier studies that examined the amputation rehabilitation services received by veterans with ULA pointed to quality gaps in care and differences in satisfaction in the VA and DoD when compared with the civilian sector but were limited in their scope and methodology.^7,8 A 2008 study of veterans of the Vietnam War, Operation Iraqi Freedom (OIF), and Operation Enduring Freedom (OEF) compared satisfaction by location of care receipt (DoD only, VA only, private only, and multiple sources). That study dichotomized response categories for items related to satisfaction with care (satisfied/not), but did not estimate degree of satisfaction, calculate summary scores of the items, or utilize validated care satisfaction metrics. That study found that a greater proportion of Vietnam War veterans (compared with OIF/OEF veterans receiving care in the private sector) agreed that they “had a role in choosing prosthesis” and disagreed that they wanted to change their current prosthesis to another type.⁷ The assumption made by the authors is that much of this private sector care was actually VA-sponsored care prescribed and procured by the VA but delivered in the community. However, no data were collected to confirm or refute this assumption, and it is possible that some care was both VA sponsored and delivered, some was VA sponsored but commercially delivered, and in some cases, care was sponsored by other sources and delivered in still other facilities.

A 2012 VA Office of the Inspector General study of OIF, OEF, and Operation New Dawn (OND) veterans reported lower prosthetic satisfaction for veterans with upper limb when compared with lower limb amputation and described respondents concerns about lack of VA prosthetic expertise, difficulty with accessing VA services, and dissatisfaction with the sometimes lengthy approval process for obtaining fee-basis or VA contract care.⁸ Although this report suggested that there were quality gaps and areas for improvement, it did not employ validated metrics of prosthesis or care satisfaction and instead relied on qualitative data collected through telephone interviews.

Given the VA effort to enhance the quality and consistency of its amputation care services through the formal establishment of the Amputation System of Care, which began in 2008, further evaluation of care satisfaction and quality of care is warranted. In 2014 the VA and DoD released the first evidence-based clinical practice guidelines (CPGs) for the rehabilitation of persons with ULA.² The CPG describes care paths to improve outcomes and basic tenets of amputation rehabilitation care and can be used to identify process activities that are essential aspects of quality care. However, the extent to which the CPG has impacted the quality and timeliness of care for veterans with ULA are presently unclear.

Thus, the purposes of this study were to: (1) measure veteran satisfaction with prosthetic limb care and identify factors associated with service satisfaction; (2) assess quality indicators that potentially reflect CPG) adoption; (3) compare care satisfaction and quality for those who received care in or outside of the VA or DoD; and (4) evaluate change in satisfaction over time.

Methods

The study was approved by the VA Central Institutional Review Board (IRB) (Study #16-20) and Human Research Protection Office, U.S. Army Medical Research and Development Command. The sampling frame consisted of veterans with major ULA who received care in the VA between 2010 and 2015 identified in VA Corporate Data Warehouse. We sent recruitment packages to nondeceased veterans who had current addresses and phone numbers. Those who did not opt out or inform us that they did not meet eligibility criteria were contacted by study interviewers. A waiver of documentation of written informed consent was obtained from the VA Central IRB. When reached by the study interviewer, Veterans provided oral informed consent. At baseline, 808 veterans were interviewed for a response rate of 47.7% as calculated by the American Association for Public Opinion Research (AAPOR) methodology.⁹ Follow-up interviews approximately 1 year later (mean [SD] 367 [16.8] days), were conducted with 585 respondents for a 72.4% response rate (Figure).

Survey Content

Development and pilot testing of the survey instrument previously was reported.¹ The content of the survey drew from existing survey items and metrics, and included new items specifically designed to address patterns of amputation care, based on care goals within the CPG. All new and modified items were tested and refined through cognitive interviews with 10 participants, and tested with an additional 13 participants.

The survey collected data on demographics, amputation characteristics (year of amputation, level, laterality, and etiology), current prosthesis use, and type of prosthesis. This article focused on the sections of the survey pertaining to satisfaction with prosthetic care and indicators of quality of care. A description of the content of the full survey and a synopsis of overall findings are reported in a prior publication.¹ The key independent, dependent, and other variables utilized in the analyses reported in this manuscript are described below.

Primary Independent Variables

In the follow-up survey, we asked respondents whether they had any amputation care in the prior 12 months, and if so to indicate where they had gone for care. We categorized respondents as having received VA/DoD care if they reported any care at the VA or DoD, and as having received non-VA/DoD care if they did not report care at the VA or DoD but indicated that they had received amputation care between baseline and follow-up.

Two primary outcomes were utilized; the Orthotics and Prosthetics User’s Survey (OPUS), client satisfaction with services scale (CSS), and a measure of care quality specifically developed for this study. The CSS is a measure developed specifically for orthotic and prosthesis users.¹⁰ This 11-item scale measures satisfaction with prosthetic limb services and contains items evaluating facets of care such as courtesy received from prosthetists and clinical staff, care coordination, appointment wait time, willingness of the prosthetist to listen to participant concerns, and satisfaction with prosthesis training. Items are rated on a 4-point scale (strongly agree [1] to strongly disagree [4]), thus higher CSS scores indicate worse satisfaction with services. The CSS was administered only to prosthesis users.

The Quality of Care assessment developed for this study contained items pertaining to amputation related care receipt and care quality. These items were generated by the study team in consultation with representatives from the VA/DoD Extremity Amputation Center of Excellence after review of the ULA rehabilitation CPG. Survey questions asked respondents about the clinicians visited for amputation related care in the past 12 months, whether they had an annual amputation-related checkup, whether any clinician had assessed their function, worked with them to identify goals, and/or to develop an amputation-related care plan. Respondents were also asked whether there had been family/caregiver involvement in their care and care coordination, whether a peer visitor was involved in their initial care, whether they had received information about amputation management in the prior year, and whether they had amputation-related pain. Those that indicated that they had amputation-related pain were subsequently asked whether their pain was well managed, whether they used medication for pain management, and whether they used any nonpharmaceutical strategies.

Quality of Care Index

We initially developed 15 indicator items of quality of care. We selected 7 of the items to create a summary index. We omitted 3 items about pain management, since these items were completed only by participants who indicated that they had experienced pain; however, we examined the 3 pain items individually given the importance of this topic. We omitted an additional 2 items from the summary index because they would not be sensitive to change because they pertained to the care in the year after initial amputation. One of these items asked whether caregivers were involved in initial amputation management and the other asked whether a peer visit occurred after amputation. Another 3 items were omitted because they only were completed by small subsamples due to intentional skip patterns in the survey. These items addressed whether clinical HCPs discussed amputation care goals in the prior year, worked to develop a care plan in the prior year, or helped to coordinate care after a move. Completion rates for all items considered for the index are shown in eAppendix 1 (Available at doi:10.12788/fp.0096). After item selection, we generated an index score, which was the number of reported “yes” responses to the seven relevant items.

Other Variables

We created a single variable called level/laterality which categorized ULA as unilateral or bilateral. We further categorized respondents with unilateral amputation by their amputation level. We categorized respondents as transradial for wrist joint or below the elbow amputations; transhumeral for at or above the elbow amputations; and shoulder for shoulder joint or forequarter amputations. Participants indicated the amputation etiology using 7 yes/no variables: combat injury, accident, burn, cancer, diabetes mellitus, and infection. Participants could select ≥ 1 etiology.

Primary prosthesis type was categorized as body powered, myoelectric/hybrid, cosmetic, other/unknown, or nonuser. The service era was classified based on amputation date as Before Vietnam, Vietnam War, After Vietnam to Gulf War, After Gulf War to September 10, 2001, and September 11, 2001 to present. For race, individuals with > 1 race were classified as other. We classified participants by region, using the station identification of the most recent VA medical center that they had visited between January 1, 2010 and December 30, 2015.

The survey also employed 2 measures of satisfaction with the prosthesis, the Trinity Amputation and Prosthetic Experience Scale (TAPES) satisfaction scale and the OPUS Client Satisfaction with Devices (CSD). TAPES consists of 10 items addressing color, shape, noise, appearance, weight, usefulness, reliability, fit, comfort and overall satisfaction.¹¹ Items are rated on a 5-point Likert scale from very dissatisfied (1) to very satisfied (5). An 8-item version of the CSD scale was created for this study, after conducting a Rasch analysis (using Winsteps version 4.4.2) of the original 11-item CSD. The 8 items assess satisfaction with prosthesis fit, weight, comfort, donning ease, appearance, durability, skin contact, and pain. Items are rated on a 4-point scale from strongly agree (1) to strongly disagree (4); higher CSD scores indicate less satisfaction with devices. Psychometric analysis of the revised CSD score was reported in a prior publication.¹² We also reported on the CSS using the original 10-item measure.

Data Analyses

We described characteristics of respondents at baseline and follow-up. We used baseline data to calculate CSS scores and described scores for all participants, for subgroups of unilateral and bilateral amputees, and for unilateral amputees stratified by amputation level. Wilcoxon rank sum tests were used to compare the CSS item and total scores of 461 prosthesis users with unilateral amputation and 29 with bilateral amputation. To identify factors that we hypothesized might be associated with CSS scores at baseline, we developed separate bivariate linear regression models. We added those factors that were associated with CSS scores at P ≤ .1 in bivariate analyses to a multivariable linear regression model of factors associated with CSS score. The P ≤ .1 threshold was used to ensure that relevant confounders were controlled for in regression models. We excluded 309 participants with no reported prosthesis use (who were not asked to complete the CSS), 20 participants with other/unknown prosthesis types, and 106 with missing data on amputation care in the prior year or on satisfaction metrics. We used baseline data for this analysis to maximize the sample size.

We compared CSS scores for those who reported receiving care within or outside of the VA or DoD in the prior year, using Wilcoxon Mann-Whitney rank tests. We also compared scores of individual quality of care items for these groups using Fisher exact tests. We chose to examine individual items rather than the full Index because several items specified care receipt within the VA and thus would be inappropriate to utilize in comparisons by site location; however, we described responses to all items. In these analyses, we excluded 2 respondents who had conflicting information regarding location of care. We used follow-up data for this analysis because it allowed us to identify location of care received in the prior year.

We also described the CSS scores, the 7-item Quality of Care Index and responses to other items related to quality of care at baseline and follow-up. To examine whether satisfaction with prosthetic care or aspects of care quality had changed over time, we compared baseline and follow-up CSS and quality of care scores for respondents who had measures at both times using Wilcoxon signed ranks tests. Individual items were compared using McNemar tests.

Results

Respondents were 97.4% male and included 776 unilateral amputees and 32 bilateral amputees with a mean (SD) age of 63.3 (14.1) years (Table 1). Respondents had lost their limbs a mean (SD) 31.4 (14.1) years prior, and half were transradial, 34.2% transhumeral, and 11.6% shoulder amputation. At baseline 185 (22.9%) participants received amputation-related care in the prior year and 118 (20.2%) participants received amputation-related care within 1 year of follow-up. Of respondents, 113 (19.3%) stated that their care was between baseline and follow-up and 89 (78.8%) of these received care at either the VA, the DoD or both; just 16 (14.2%) received care elsewhere.

Mean (SD) CSS scores were highest (lower satisfaction) for those with amputation at the shoulder and lowest for those with transhumeral amputation: 42.2 (20.0) vs 33.4 (20.8). Persons with bilateral amputation were less satisfied in almost every category when compared with those with unilateral amputation, although the total CSS score was not substantially different. Wilcoxon rank sum analyses revealed statistically significant differences in wait time satisfaction: bilateral amputees were less satisfied than unilateral amputees. Factors associated with overall CSS score in bivariate analyses were CSD score, TAPES score, amputation care receipt, prosthesis type, race, and region of care (eAppendix 2, available at doi:10.12788/fp.0096).

Discussion

Our longitudinal study provides insights into the experiences of veterans with major ULA related to satisfaction with prosthetic limb care services and receipt of amputation-related care. We reported on the development and use of a new summary measure of amputation care quality, which we designed to capture some of the key elements of care quality as provided in the VA/DoD CPG.²

We used baseline data to identify factors independently associated with prosthetic limb care satisfaction as measured by a previously validated measure, the OPUS CSS. The CSS addresses satisfaction with prosthetic limb services and does not reflect satisfaction with other amputation care services. We found that persons who received amputation care in the prior year had CSS scores that were a mean 5.1 points better than those who had not received recent care. Although causality cannot be determined with this investigation, this finding highlights an important relationship between frequency of care and satisfaction, which can be leveraged by the VA in future care initiatives. Care satisfaction was also better by 0.7 points for every 1-point decrease (indicating higher satisfaction) in the OPUS CSD prosthetic satisfaction scale. This finding isn’t surprising, given that a major purpose of prosthetic limb care services is to procure and fit a satisfactory device. To determine whether these same relationships were observed in the smaller, longitudinal cohort data at follow-up, we repeated these models and found similar relationships between recent care receipt and prosthesis satisfaction and satisfaction with services. We believe that these findings are meaningful and emphasize the importance of both service and device satisfaction to the veteran with an ULA. Lower service satisfaction scores among those with amputations at the shoulder and those with bilateral limb loss suggest that these individuals may benefit from different service delivery approaches.

We did observe a difference in satisfaction scores by geographic region in the follow-up (but not the baseline) data with satisfaction higher in the Western vs the Southern region (data not shown). This finding suggests a need for continued monitoring of care satisfaction over time to determine whether differences by region persist. We grouped respondents into geographic region based on the location where they had received their most recent VA care of any type. Many veterans receive care at multiple VA locations. Thus, it is possible that some veterans received their amputation care at a non-VA facility or a VA facility in a different region.

Our findings related to prosthetic limb care services satisfaction are generalizable to veteran prosthesis users. Findings may not be generalizable to nonusers, because in our study, the CSS only was administered to prosthesis users. Thus, we were unable to identify factors associated with care satisfaction for persons who were not current users of an upper limb prosthesis.

The study findings confirmed that most veterans with ULA receive amputation-related care in the VA or DoD. We compared CSS and Quality of Care item scores for those who reported receiving care at the VA or DoD vs elsewhere. Amputation care within the VA is complex. Some services are provided at VA facilities and some are ordered by VA clinicians but provided by community-based HCPs. However, we found that better (though not statistically significantly different) CSS scores and several Quality of Care items were endorsed by a significantly more of those reporting care in the VA or DoD as compared to elsewhere. Given the dissemination of a rehabilitation of upper limb amputees CPG, we hypothesized that VA and DoD HCPs would be more aware of care guidelines and would provide better care. Overall, our findings supported this hypothesis while also suggesting that areas such as caregiver involvement and peer visitation may benefit from additional attention and program improvement.

We used longitudinal data to describe and compare CSS and Quality of Care Index scores. Our analyses did not detect any statistically significant differences between baseline and follow-up. This finding may reflect that this was a relatively stable population with regard to amputation experiences given the mean time since amputation was 31.4 years. However, we also recognize that our measures may not have captured all aspects of care satisfaction or quality. It is possible that there were other changes that had occurred over the course of the year that were not captured by the CSS or by the Quality of Care Index. It is also possible that some implementation and adoption of the CPG had happened prior to our baseline survey. Finally, it is possible that some elements of the CPG have not yet been fully integrated into clinical care. We believe that the latter is likely, given that nearly 80% of respondents did not report receiving any amputation care within the past year at follow-up, though the CPGs recommend an annual visit.

Aside from recall bias, 2 explanations must be considered relative to the low rate of adherence to the CPG recommendation for an annual follow-up. The first is that the CPG simply may not be widely adopted. The second is that the majority of patients with ULA who use prostheses use a body-powered system. These tend to be low maintenance, long-lasting systems and may ultimately not need annual maintenance and repair. Further, if the veteran’s body-powered system is functioning properly and health status has not changed, they may simply be opting out of an annual visit despite the CPG recommendation. Nonetheless, this apparent low rate of annual follow-up emphasizes the need for additional process improvement measures for the VA.

Strengths and Limitations

The VA provides a unique setting for a nationally representative study of amputation rehabilitation because it has centralized data sources that can be used to identify veterans with ULA. Our study had a strong response rate, and its prosthetic limb care satisfaction findings are generalizable to all veterans with major ULA who received VA care from 2010 to 2015. However, there are limits to generalizability outside of this population to civilians or to veterans who do not receive VA care. To examine possible nonresponse bias, which could limit generalizability, we compared the baseline characteristics of respondents and nonrespondents to the follow-up study (eAppendix 4 available at doi:10.12788/fp.0096). There were no significant differences in satisfaction, quality of care, or receipt of amputation-related care between those lost to follow-up and those with follow-up data. Although, we did find small differences in gender, race, and service era (defined by amputation date). We do not believe that these differences threaten the interpretation of findings at follow-up, but there may be limits to generalizability of these findings to the full baseline sample. The data were from a telephone survey of veterans. It is possible that some veterans did not recall their care receipt or did not understand some of the questions and thus may not have accurately answered questions related to type of care received or the timing of that care.

Our interpretation of findings comparing care received within the VA and DoD or elsewhere is also limited because we cannot say with certainty whether those who indicated no care in the VA or DoD actually had care that was sponsored by the VA or DoD as contract or fee-basis care. Just 8 respondents indicated that they had received care only outside of the VA or DoD in the prior year. There were also some limitations in the collection of data about care location. We asked about receipt of amputation care in the prior year and about location of any amputation care received between baseline and follow-up, and there were differences in responses. Thus, we used a combination of these items to identify location of care received in the prior year.

Despite these limitations, we believe that our study provides novel, important findings about the satisfaction with prosthetic limb care services and quality of amputation rehabilitation care for veterans. Findings from this study can be used to address amputation and prosthetic limb care satisfaction and quality weaknesses highlighted and to benchmark care satisfaction and CPG compliance. Other studies evaluating care guideline compliance have used indicators obtained from clinical records or data repositories.^13-15 Future work could combine self-reported satisfaction and care quality measures with indicators obtained from clinical or repository sources to provide a more complete snapshot of care delivery.

Conclusions

We reported on a national survey of veterans with major upper limb loss that assessed satisfaction with prosthetic limb care services and quality of amputation care. Satisfaction with prosthetic limb care was independently associated with satisfaction with the prosthesis, and receipt of care within the prior year. Most of the veterans surveyed received care within the VA or DoD and reported receiving higher quality of care, when compared with those who received care outside of the VA or DoD. Satisfaction with care and quality of care were stable over the year of this study. Data presented in this study can serve to direct VA amputation care process improvement initiatives as benchmarks for future work. Future studies are needed to track satisfaction with and quality of care for veterans with ULA.

Veterans with upper limb amputation (ULA) are a small, but important population, who have received more attention in the past decade due to the increased growth of the population of veterans with conflict-related amputation from recent military engagements. Among the 808 veterans with ULA receiving any care in the US Department of Veterans Affairs (VA) from 2010 to 2015 who participated in our national study, an estimated 28 to 35% had a conflict-related amputation.¹ The care of these individuals with ULA is highly specialized, and there is a recognized shortage of experienced professionals in this area.^2,3 The provision of high-quality prosthetic care is increasingly complex with advances in technology, such as externally powered devices with multiple functions.

The VA is a comprehensive, integrated health care system that serves more than 8.9 million veterans each year. Interdisciplinary amputation care is provided within the VA through a traditional clinic setting or by using one of several currently available virtual care modalities.^4,5 In consultation with the veteran, VA health care providers (HCPs) prescribe prostheses and services based on the clinical needs and furnish authorized items and services to eligible veterans. Prescribed items and/or services are furnished either by internal VA resources or through a community-based prosthetist who is an authorized vendor or contractor. Although several studies have reported that the majority of veterans with ULA utilize VA services for at least some aspects of their health care, little is known about: (1) prosthetic limb care satisfaction or the quality of care that veterans receive; or (2) how care within the VA or Department of Defense (DoD) compares with care provided in the civilian sector.^6-8

Earlier studies that examined the amputation rehabilitation services received by veterans with ULA pointed to quality gaps in care and differences in satisfaction in the VA and DoD when compared with the civilian sector but were limited in their scope and methodology.^7,8 A 2008 study of veterans of the Vietnam War, Operation Iraqi Freedom (OIF), and Operation Enduring Freedom (OEF) compared satisfaction by location of care receipt (DoD only, VA only, private only, and multiple sources). That study dichotomized response categories for items related to satisfaction with care (satisfied/not), but did not estimate degree of satisfaction, calculate summary scores of the items, or utilize validated care satisfaction metrics. That study found that a greater proportion of Vietnam War veterans (compared with OIF/OEF veterans receiving care in the private sector) agreed that they “had a role in choosing prosthesis” and disagreed that they wanted to change their current prosthesis to another type.⁷ The assumption made by the authors is that much of this private sector care was actually VA-sponsored care prescribed and procured by the VA but delivered in the community. However, no data were collected to confirm or refute this assumption, and it is possible that some care was both VA sponsored and delivered, some was VA sponsored but commercially delivered, and in some cases, care was sponsored by other sources and delivered in still other facilities.

A 2012 VA Office of the Inspector General study of OIF, OEF, and Operation New Dawn (OND) veterans reported lower prosthetic satisfaction for veterans with upper limb when compared with lower limb amputation and described respondents concerns about lack of VA prosthetic expertise, difficulty with accessing VA services, and dissatisfaction with the sometimes lengthy approval process for obtaining fee-basis or VA contract care.⁸ Although this report suggested that there were quality gaps and areas for improvement, it did not employ validated metrics of prosthesis or care satisfaction and instead relied on qualitative data collected through telephone interviews.

Given the VA effort to enhance the quality and consistency of its amputation care services through the formal establishment of the Amputation System of Care, which began in 2008, further evaluation of care satisfaction and quality of care is warranted. In 2014 the VA and DoD released the first evidence-based clinical practice guidelines (CPGs) for the rehabilitation of persons with ULA.² The CPG describes care paths to improve outcomes and basic tenets of amputation rehabilitation care and can be used to identify process activities that are essential aspects of quality care. However, the extent to which the CPG has impacted the quality and timeliness of care for veterans with ULA are presently unclear.

Thus, the purposes of this study were to: (1) measure veteran satisfaction with prosthetic limb care and identify factors associated with service satisfaction; (2) assess quality indicators that potentially reflect CPG) adoption; (3) compare care satisfaction and quality for those who received care in or outside of the VA or DoD; and (4) evaluate change in satisfaction over time.

Methods

The study was approved by the VA Central Institutional Review Board (IRB) (Study #16-20) and Human Research Protection Office, U.S. Army Medical Research and Development Command. The sampling frame consisted of veterans with major ULA who received care in the VA between 2010 and 2015 identified in VA Corporate Data Warehouse. We sent recruitment packages to nondeceased veterans who had current addresses and phone numbers. Those who did not opt out or inform us that they did not meet eligibility criteria were contacted by study interviewers. A waiver of documentation of written informed consent was obtained from the VA Central IRB. When reached by the study interviewer, Veterans provided oral informed consent. At baseline, 808 veterans were interviewed for a response rate of 47.7% as calculated by the American Association for Public Opinion Research (AAPOR) methodology.⁹ Follow-up interviews approximately 1 year later (mean [SD] 367 [16.8] days), were conducted with 585 respondents for a 72.4% response rate (Figure).

Survey Content

Development and pilot testing of the survey instrument previously was reported.¹ The content of the survey drew from existing survey items and metrics, and included new items specifically designed to address patterns of amputation care, based on care goals within the CPG. All new and modified items were tested and refined through cognitive interviews with 10 participants, and tested with an additional 13 participants.

The survey collected data on demographics, amputation characteristics (year of amputation, level, laterality, and etiology), current prosthesis use, and type of prosthesis. This article focused on the sections of the survey pertaining to satisfaction with prosthetic care and indicators of quality of care. A description of the content of the full survey and a synopsis of overall findings are reported in a prior publication.¹ The key independent, dependent, and other variables utilized in the analyses reported in this manuscript are described below.

Primary Independent Variables

In the follow-up survey, we asked respondents whether they had any amputation care in the prior 12 months, and if so to indicate where they had gone for care. We categorized respondents as having received VA/DoD care if they reported any care at the VA or DoD, and as having received non-VA/DoD care if they did not report care at the VA or DoD but indicated that they had received amputation care between baseline and follow-up.

Two primary outcomes were utilized; the Orthotics and Prosthetics User’s Survey (OPUS), client satisfaction with services scale (CSS), and a measure of care quality specifically developed for this study. The CSS is a measure developed specifically for orthotic and prosthesis users.¹⁰ This 11-item scale measures satisfaction with prosthetic limb services and contains items evaluating facets of care such as courtesy received from prosthetists and clinical staff, care coordination, appointment wait time, willingness of the prosthetist to listen to participant concerns, and satisfaction with prosthesis training. Items are rated on a 4-point scale (strongly agree [1] to strongly disagree [4]), thus higher CSS scores indicate worse satisfaction with services. The CSS was administered only to prosthesis users.

The Quality of Care assessment developed for this study contained items pertaining to amputation related care receipt and care quality. These items were generated by the study team in consultation with representatives from the VA/DoD Extremity Amputation Center of Excellence after review of the ULA rehabilitation CPG. Survey questions asked respondents about the clinicians visited for amputation related care in the past 12 months, whether they had an annual amputation-related checkup, whether any clinician had assessed their function, worked with them to identify goals, and/or to develop an amputation-related care plan. Respondents were also asked whether there had been family/caregiver involvement in their care and care coordination, whether a peer visitor was involved in their initial care, whether they had received information about amputation management in the prior year, and whether they had amputation-related pain. Those that indicated that they had amputation-related pain were subsequently asked whether their pain was well managed, whether they used medication for pain management, and whether they used any nonpharmaceutical strategies.

Quality of Care Index

We initially developed 15 indicator items of quality of care. We selected 7 of the items to create a summary index. We omitted 3 items about pain management, since these items were completed only by participants who indicated that they had experienced pain; however, we examined the 3 pain items individually given the importance of this topic. We omitted an additional 2 items from the summary index because they would not be sensitive to change because they pertained to the care in the year after initial amputation. One of these items asked whether caregivers were involved in initial amputation management and the other asked whether a peer visit occurred after amputation. Another 3 items were omitted because they only were completed by small subsamples due to intentional skip patterns in the survey. These items addressed whether clinical HCPs discussed amputation care goals in the prior year, worked to develop a care plan in the prior year, or helped to coordinate care after a move. Completion rates for all items considered for the index are shown in eAppendix 1 (Available at doi:10.12788/fp.0096). After item selection, we generated an index score, which was the number of reported “yes” responses to the seven relevant items.

Other Variables

We created a single variable called level/laterality which categorized ULA as unilateral or bilateral. We further categorized respondents with unilateral amputation by their amputation level. We categorized respondents as transradial for wrist joint or below the elbow amputations; transhumeral for at or above the elbow amputations; and shoulder for shoulder joint or forequarter amputations. Participants indicated the amputation etiology using 7 yes/no variables: combat injury, accident, burn, cancer, diabetes mellitus, and infection. Participants could select ≥ 1 etiology.

Primary prosthesis type was categorized as body powered, myoelectric/hybrid, cosmetic, other/unknown, or nonuser. The service era was classified based on amputation date as Before Vietnam, Vietnam War, After Vietnam to Gulf War, After Gulf War to September 10, 2001, and September 11, 2001 to present. For race, individuals with > 1 race were classified as other. We classified participants by region, using the station identification of the most recent VA medical center that they had visited between January 1, 2010 and December 30, 2015.

The survey also employed 2 measures of satisfaction with the prosthesis, the Trinity Amputation and Prosthetic Experience Scale (TAPES) satisfaction scale and the OPUS Client Satisfaction with Devices (CSD). TAPES consists of 10 items addressing color, shape, noise, appearance, weight, usefulness, reliability, fit, comfort and overall satisfaction.¹¹ Items are rated on a 5-point Likert scale from very dissatisfied (1) to very satisfied (5). An 8-item version of the CSD scale was created for this study, after conducting a Rasch analysis (using Winsteps version 4.4.2) of the original 11-item CSD. The 8 items assess satisfaction with prosthesis fit, weight, comfort, donning ease, appearance, durability, skin contact, and pain. Items are rated on a 4-point scale from strongly agree (1) to strongly disagree (4); higher CSD scores indicate less satisfaction with devices. Psychometric analysis of the revised CSD score was reported in a prior publication.¹² We also reported on the CSS using the original 10-item measure.

Data Analyses

We described characteristics of respondents at baseline and follow-up. We used baseline data to calculate CSS scores and described scores for all participants, for subgroups of unilateral and bilateral amputees, and for unilateral amputees stratified by amputation level. Wilcoxon rank sum tests were used to compare the CSS item and total scores of 461 prosthesis users with unilateral amputation and 29 with bilateral amputation. To identify factors that we hypothesized might be associated with CSS scores at baseline, we developed separate bivariate linear regression models. We added those factors that were associated with CSS scores at P ≤ .1 in bivariate analyses to a multivariable linear regression model of factors associated with CSS score. The P ≤ .1 threshold was used to ensure that relevant confounders were controlled for in regression models. We excluded 309 participants with no reported prosthesis use (who were not asked to complete the CSS), 20 participants with other/unknown prosthesis types, and 106 with missing data on amputation care in the prior year or on satisfaction metrics. We used baseline data for this analysis to maximize the sample size.

We compared CSS scores for those who reported receiving care within or outside of the VA or DoD in the prior year, using Wilcoxon Mann-Whitney rank tests. We also compared scores of individual quality of care items for these groups using Fisher exact tests. We chose to examine individual items rather than the full Index because several items specified care receipt within the VA and thus would be inappropriate to utilize in comparisons by site location; however, we described responses to all items. In these analyses, we excluded 2 respondents who had conflicting information regarding location of care. We used follow-up data for this analysis because it allowed us to identify location of care received in the prior year.

We also described the CSS scores, the 7-item Quality of Care Index and responses to other items related to quality of care at baseline and follow-up. To examine whether satisfaction with prosthetic care or aspects of care quality had changed over time, we compared baseline and follow-up CSS and quality of care scores for respondents who had measures at both times using Wilcoxon signed ranks tests. Individual items were compared using McNemar tests.

Results

Respondents were 97.4% male and included 776 unilateral amputees and 32 bilateral amputees with a mean (SD) age of 63.3 (14.1) years (Table 1). Respondents had lost their limbs a mean (SD) 31.4 (14.1) years prior, and half were transradial, 34.2% transhumeral, and 11.6% shoulder amputation. At baseline 185 (22.9%) participants received amputation-related care in the prior year and 118 (20.2%) participants received amputation-related care within 1 year of follow-up. Of respondents, 113 (19.3%) stated that their care was between baseline and follow-up and 89 (78.8%) of these received care at either the VA, the DoD or both; just 16 (14.2%) received care elsewhere.

Mean (SD) CSS scores were highest (lower satisfaction) for those with amputation at the shoulder and lowest for those with transhumeral amputation: 42.2 (20.0) vs 33.4 (20.8). Persons with bilateral amputation were less satisfied in almost every category when compared with those with unilateral amputation, although the total CSS score was not substantially different. Wilcoxon rank sum analyses revealed statistically significant differences in wait time satisfaction: bilateral amputees were less satisfied than unilateral amputees. Factors associated with overall CSS score in bivariate analyses were CSD score, TAPES score, amputation care receipt, prosthesis type, race, and region of care (eAppendix 2, available at doi:10.12788/fp.0096).

Discussion

Our longitudinal study provides insights into the experiences of veterans with major ULA related to satisfaction with prosthetic limb care services and receipt of amputation-related care. We reported on the development and use of a new summary measure of amputation care quality, which we designed to capture some of the key elements of care quality as provided in the VA/DoD CPG.²

We used baseline data to identify factors independently associated with prosthetic limb care satisfaction as measured by a previously validated measure, the OPUS CSS. The CSS addresses satisfaction with prosthetic limb services and does not reflect satisfaction with other amputation care services. We found that persons who received amputation care in the prior year had CSS scores that were a mean 5.1 points better than those who had not received recent care. Although causality cannot be determined with this investigation, this finding highlights an important relationship between frequency of care and satisfaction, which can be leveraged by the VA in future care initiatives. Care satisfaction was also better by 0.7 points for every 1-point decrease (indicating higher satisfaction) in the OPUS CSD prosthetic satisfaction scale. This finding isn’t surprising, given that a major purpose of prosthetic limb care services is to procure and fit a satisfactory device. To determine whether these same relationships were observed in the smaller, longitudinal cohort data at follow-up, we repeated these models and found similar relationships between recent care receipt and prosthesis satisfaction and satisfaction with services. We believe that these findings are meaningful and emphasize the importance of both service and device satisfaction to the veteran with an ULA. Lower service satisfaction scores among those with amputations at the shoulder and those with bilateral limb loss suggest that these individuals may benefit from different service delivery approaches.

We did observe a difference in satisfaction scores by geographic region in the follow-up (but not the baseline) data with satisfaction higher in the Western vs the Southern region (data not shown). This finding suggests a need for continued monitoring of care satisfaction over time to determine whether differences by region persist. We grouped respondents into geographic region based on the location where they had received their most recent VA care of any type. Many veterans receive care at multiple VA locations. Thus, it is possible that some veterans received their amputation care at a non-VA facility or a VA facility in a different region.

Our findings related to prosthetic limb care services satisfaction are generalizable to veteran prosthesis users. Findings may not be generalizable to nonusers, because in our study, the CSS only was administered to prosthesis users. Thus, we were unable to identify factors associated with care satisfaction for persons who were not current users of an upper limb prosthesis.

The study findings confirmed that most veterans with ULA receive amputation-related care in the VA or DoD. We compared CSS and Quality of Care item scores for those who reported receiving care at the VA or DoD vs elsewhere. Amputation care within the VA is complex. Some services are provided at VA facilities and some are ordered by VA clinicians but provided by community-based HCPs. However, we found that better (though not statistically significantly different) CSS scores and several Quality of Care items were endorsed by a significantly more of those reporting care in the VA or DoD as compared to elsewhere. Given the dissemination of a rehabilitation of upper limb amputees CPG, we hypothesized that VA and DoD HCPs would be more aware of care guidelines and would provide better care. Overall, our findings supported this hypothesis while also suggesting that areas such as caregiver involvement and peer visitation may benefit from additional attention and program improvement.

We used longitudinal data to describe and compare CSS and Quality of Care Index scores. Our analyses did not detect any statistically significant differences between baseline and follow-up. This finding may reflect that this was a relatively stable population with regard to amputation experiences given the mean time since amputation was 31.4 years. However, we also recognize that our measures may not have captured all aspects of care satisfaction or quality. It is possible that there were other changes that had occurred over the course of the year that were not captured by the CSS or by the Quality of Care Index. It is also possible that some implementation and adoption of the CPG had happened prior to our baseline survey. Finally, it is possible that some elements of the CPG have not yet been fully integrated into clinical care. We believe that the latter is likely, given that nearly 80% of respondents did not report receiving any amputation care within the past year at follow-up, though the CPGs recommend an annual visit.

Aside from recall bias, 2 explanations must be considered relative to the low rate of adherence to the CPG recommendation for an annual follow-up. The first is that the CPG simply may not be widely adopted. The second is that the majority of patients with ULA who use prostheses use a body-powered system. These tend to be low maintenance, long-lasting systems and may ultimately not need annual maintenance and repair. Further, if the veteran’s body-powered system is functioning properly and health status has not changed, they may simply be opting out of an annual visit despite the CPG recommendation. Nonetheless, this apparent low rate of annual follow-up emphasizes the need for additional process improvement measures for the VA.

Strengths and Limitations

The VA provides a unique setting for a nationally representative study of amputation rehabilitation because it has centralized data sources that can be used to identify veterans with ULA. Our study had a strong response rate, and its prosthetic limb care satisfaction findings are generalizable to all veterans with major ULA who received VA care from 2010 to 2015. However, there are limits to generalizability outside of this population to civilians or to veterans who do not receive VA care. To examine possible nonresponse bias, which could limit generalizability, we compared the baseline characteristics of respondents and nonrespondents to the follow-up study (eAppendix 4 available at doi:10.12788/fp.0096). There were no significant differences in satisfaction, quality of care, or receipt of amputation-related care between those lost to follow-up and those with follow-up data. Although, we did find small differences in gender, race, and service era (defined by amputation date). We do not believe that these differences threaten the interpretation of findings at follow-up, but there may be limits to generalizability of these findings to the full baseline sample. The data were from a telephone survey of veterans. It is possible that some veterans did not recall their care receipt or did not understand some of the questions and thus may not have accurately answered questions related to type of care received or the timing of that care.

Our interpretation of findings comparing care received within the VA and DoD or elsewhere is also limited because we cannot say with certainty whether those who indicated no care in the VA or DoD actually had care that was sponsored by the VA or DoD as contract or fee-basis care. Just 8 respondents indicated that they had received care only outside of the VA or DoD in the prior year. There were also some limitations in the collection of data about care location. We asked about receipt of amputation care in the prior year and about location of any amputation care received between baseline and follow-up, and there were differences in responses. Thus, we used a combination of these items to identify location of care received in the prior year.

Despite these limitations, we believe that our study provides novel, important findings about the satisfaction with prosthetic limb care services and quality of amputation rehabilitation care for veterans. Findings from this study can be used to address amputation and prosthetic limb care satisfaction and quality weaknesses highlighted and to benchmark care satisfaction and CPG compliance. Other studies evaluating care guideline compliance have used indicators obtained from clinical records or data repositories.^13-15 Future work could combine self-reported satisfaction and care quality measures with indicators obtained from clinical or repository sources to provide a more complete snapshot of care delivery.

Conclusions

We reported on a national survey of veterans with major upper limb loss that assessed satisfaction with prosthetic limb care services and quality of amputation care. Satisfaction with prosthetic limb care was independently associated with satisfaction with the prosthesis, and receipt of care within the prior year. Most of the veterans surveyed received care within the VA or DoD and reported receiving higher quality of care, when compared with those who received care outside of the VA or DoD. Satisfaction with care and quality of care were stable over the year of this study. Data presented in this study can serve to direct VA amputation care process improvement initiatives as benchmarks for future work. Future studies are needed to track satisfaction with and quality of care for veterans with ULA.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

THE CASE

A 14-year-old girl with no significant medical history presented to the office accompanied by her mother for a routine well-adolescent visit. She attended school online due to a history of severe bullying and, when interviewed alone, admitted to a lack of a social life as a result. On questioning, she denied tobacco, alcohol, or illicit drug use. Her gender identity was female. Her sexual orientation was toward both males and females, but she was not sexually active. She denied exposure to physical or emotional violence at home and said she did not feel depressed or think about suicide.

Physical examination revealed multiple erythematous linear scars surrounding the areola of both breasts. When questioned about these lesions, she admitted to cutting herself on the breasts during the past several months but again denied suicidal intent. She believed that her behavior was a normal coping mechanism. 

The physical exam was otherwise normal. Lab results, including thyroid-stimulating hormone and complete blood count, were within normal limits.

THE DIAGNOSIS

The physical exam findings and the patient’s self report pointed to a diagnosis of nonsuicidal self-injurious (NSSI) behavior involving cutting.

DISCUSSION

The NSSI behavior displayed by this patient is a common biopsychosocial disorder observed in adolescents. Self-injury is defined as the deliberate injuring of body tissues without suicidal intent.¹ Self-injurious behavior typically begins when patients are 13 to 16 years of age, and cutting is the most common form. Most acts occur on the arms, legs, wrists, and stomach.² Studies have shown that the prevalence of this behavior is on the rise among adolescents, from about 7% in 2014 to between 14% and 24% in 2015.³

Risk for suicide. Although a feature of NSSI is the lack of suicidal intent, this type of high-risk behavior is associated with past, present, and future suicide attempts. It is important for physicians to identify NSSI in an adolescent, as it is linked to a 7-fold increased risk for a suicide attempt.³

Screening for NSSI. Less than one-fifth of adolescents who injure themselves come to the attention of health care providers.⁴ We propose that primary care physicians add NSSI to the list of risky behaviors—including drug abuse, sexual activity, and depression—for which they screen during well-child visits.

Continue to: Identifying risk factors

Identifying risk factors. The case patient experienced bullying and reported a nonheterosexual orientation, both of which have been demonstrated as strong risk factors for NSSI.⁵ Female gender has also been identified as a risk factor for NSSI.³

In adolescent psychiatric samples, prevalence rates of NSSI were found to be as high as 60% for 1 incident of NSSI and around 50% for repetitive NSSI.⁶ NSSI coincides with other psychiatric comorbidities, including eating disorders, mood disorders (depression), anxiety disorders, posttraumatic stress disorder, and borderline personality disorder.³ In a study of 93 subjects, each of whom was a self-reported abuse survivor with a history of self-injury, 96% were in therapy for diagnoses that included posttraumatic stress disorder (73%), dissociative disorder (40%), borderline personality disorder (37%), and multiple personality disorder (29%).⁷

Some patients may self-harm to generate feeling when emotionally empty or to avert suicidal intent.

The experience of adverse childhood events also increases risk for NSSI. This includes parental neglect, abuse, or deprivation.⁶ Insecure paternal attachment and parental neglect are significant predictors for women, while childhood separation is a primary predictor for men.⁸ Indirect childhood maltreatment, such as witnessing domestic violence or increased parental critique, is also associated with NSSI.⁸ NSSI is also more prevalent among young people who identify with a subculture such as gothic or emo.⁶

Why they do it and how to help

In multiple studies aimed at identifying reasons for self-injury, converging evidence suggests that nearly all patients act with the intent of alleviating negative affect.⁹ Patients self-harm to regulate distress, anxiety, and frustration that they perceive to be intolerable.⁹ They may self-harm to generate feeling when emotionally empty or to avert suicidal intent.⁹ For others, self-harm is a way to communicate their distress.

How to proceed. After a physician identifies NSSI, the patient should be assessed for suicidality and medical severity of the injury.³ Factors associated with higher likelihood of suicidality in patients with NSSI include multiple self-injurious methods and locations, early age of onset, longer history of NSSI, recent worsening of the injuries, simultaneous substance use, and the perception that the patient is addicted to self-injury.¹⁰

Continue to: It is also important...

It is also important to ask the patient whether she or he has told anyone about the behavior. Participation in NSSI communities may reinforce it.³

Treatment found to be effective for NSSI involves dialectical behavioral therapy, cognitive behavioral therapy, and mentalization-based therapy.¹¹

Our patient was admitted to the hospital several weeks after her well visit because she expressed suicidal ideation. After being discharged, she was referred to outpatient Psychiatry with a treatment plan that included cognitive behavioral therapy.

THE TAKEAWAY

While our patient may have concealed her self-injurious experience because of stigma and concern about others’ reactions, there were several risk factors for NSSI in her history that prompted further investigation with a skin exam.

If a patient presents with 1 or more risk factors, an initial assessment for possible NSSI should be performed with detailed history-taking and a skin exam. Once NSSI is identified, the initial response and tone of questioning toward the patient need to convey a sense of genuine curiosity about the patient’s experience. From there, the physician can avail the patient to the proper treatment modalities.

NSSI patients can be resistant to sharing and participating in support groups. However, a referred counselor can follow up with a stepwise approach to slowly gain the trust of the individual, find the root cause, and get the patient to a point where she or he is ready to start the necessary treatment.

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

The shoulder, or glenohumeral joint, is the most commonly dislocated large joint; dislocation occurs at a rate of 23.9 per 100,000 person/years.^1,2 There are 2 types of dislocation: traumatic anterior dislocation, which accounts for roughly 90% of dislocations, and posterior dislocation (10%).³ Anterior dislocation typically occurs when the patient’s shoulder is forcefully abducted and externally rotated.

The diagnosis is made after review of the history and mechanism of injury and performance of a complete physical exam with imaging studies—the most critical component of diagnosis.⁴ Standard radiographs (anteroposterior, axillary, and scapular Y) can confirm the presence of a dislocation; once the diagnosis is confirmed, closed reduction of the joint should be performed.¹ (Methods of reduction are beyond the scope of this article but have been recently reviewed.⁵)

Risk for recurrence drives management choices

Following an initial shoulder dislocation, the risk of recurrence is high.^6,7 Rates vary based on age, pathology after dislocation, activity level, type of immobilization, and whether surgery was performed. Overall, age is the strongest predictor of recurrence: 72% of patients ages 12 to 22 years, 56% of those ages 23 to 29 years, and 27% of those older than 30 years experience recurrence.⁶ Patients who have recurrent dislocations are at risk for arthropathy, fear of instability, and worsening surgical outcomes.⁶

Reducing the risk of a recurrent shoulder dislocation has been the focus of intense study. Proponents of surgical stabilization argue that surgery—rather than a trial of conservative treatment—is best when you consider the high risk of recurrence in young athletes (the population primarily studied), the soft-tissue and bony damage caused by recurrent instability, and the predictable improvement in quality of life following surgery.

In a recent systematic review and meta-analysis, there was evidence that, for first-time traumatic shoulder dislocations, early surgery led to fewer repeat shoulder dislocations (number needed to treat [NNT] = 2-4.7). However, a significant number of patients primarily treated nonoperatively did not experience a repeat shoulder dislocation within 2 years.²

The conflicting results from randomized trials comparing operative intervention to conservative management have led surgeons and physicians in other specialties to take different approaches to the management of shoulder dislocation.² In this review, we aim to summarize considerations for conservative vs surgical management and provide clinical guidance for primary care physicians.

When to try conservative management

Although the initial treatment after a traumatic anterior shoulder dislocation has been debated, a recent meta-analysis of randomized controlled trials showed that at least half of first-time dislocations are successfully treated with conservative management.² Management can include immobilization for comfort and/or physical therapy. Age will play a role, as mentioned earlier; in general, patients older than 30 have a significant decrease in recurrence rate and are good candidates for conservative therapy.⁶ It should be noted that much of the research with regard to management of shoulder dislocations has been done in an athletic population.

Continue to: Immobilization may benefit some

Recent evidence has determined that the duration of immobilization in internal rotation does not impact recurrent instability.^8,9 In patients older than 30, the rate of repeat dislocation is lower, and early mobilization after 1 week is advocated to avoid joint stiffness and minimize the risk of adhesive capsulitis.¹⁰

Arm position during immobilization remains controversial.¹¹ In a classic study by Itoi et al, immobilization for 3 weeks in internal rotation vs 10° of external rotation was associated with a recurrence rate of 42% vs 26%, respectively.¹² In this study, immobilization in 10° of external rotation was especially beneficial for patients ages 30 years or younger.¹²

At least half of first-time dislocations are successfully treated with conservative management.

Cadaveric and magnetic resonance imaging (MRI) studies have shown external rotation may improve the odds of labral tear healing by positioning the damaged and intact parts of the glenoid labrum in closer proximity.¹³ While this is theoretically plausible, a recent Cochrane review found insufficient evidence to determine whether immobilization in external rotation has any benefits beyond those offered by internal rotation.¹⁴ A recent systematic review and meta-analysis found that immobilization in external rotation vs internal rotation after a first-time traumatic shoulder dislocation did not change outcomes.² With that said, most would prefer to immobilize in the internal rotation position for ease.

More research is needed. A Cochrane review highlighted the need for continued research.¹⁴ Additionally, most of the available randomized controlled trials to date have consisted of young men, with the majority of dislocations related to sports activities. Women, nonathletes, and older patients have been understudied to date; extrapolating current research to those groups of patients may not be appropriate and should be a focus for future research.²

Physical therapy: The conservative standard of care

Rehabilitation after glenohumeral joint dislocation is the current standard of care in conservative management to reduce the risk for repeat dislocation.¹⁵ Depending on the specific characteristics of the instability pattern, the approach may be adapted to the patient. A recent review focused on the following 4 key points: (1) restoration of rotator cuff strength, focusing on the eccentric capacity of the external rotators, (2) normalization of rotational range of motion with particular focus on internal range of motion, (3) optimization of the flexibility and muscle performance of the scapular muscles, and (4) increasing the functional sport-specific load on the shoulder girdle.

Continue to: A common approach to the care of...

A common approach to the care of a patient after a glenohumeral joint dislocation is to place the patient’s shoulder in a sling for comfort, with permitted pain-free isometric exercise along with passive and assisted elevation up to 100°.¹⁶ This is followed by a nonaggressive rehabilitation protocol for 2 months until full recovery, which includes progressive range of motion, strength, proprioception, and return to functional activities.¹⁶

An increasing number of dislocations portends a poor outcome with nonoperative treatment.

More aggressive return-to-play protocols with accelerated timelines and functional progression have been studied, including in a multicenter observational study that followed 45 contact intercollegiate athletes prospectively after in-season anterior glenohumeral instability. Thirty-three of 45 (73%) athletes returned to sport for either all or part of the season after a median 5 days lost from competition, with 12 athletes (27%) successfully completing the season without recurrence. Athletes with a subluxation event were 5.3 times more likely to return to sport during the same season, compared with those with dislocations.¹⁷

Dynamic bracing may also allow for a safe and quicker return to sport in athletes¹⁸ but recently was shown to not impact recurrent dislocation risk.¹⁹

Return to play should be based on subjective assessment as well as objective measurements of range of motion, strength, and dynamic function.¹⁵ Patients who continue to have significant weakness and pain at 2 to 3 weeks post injury despite physical therapy should be re-evaluated with an MRI for concomitant rotator cuff tears and need for surgical referral.²⁰

When to consider surgical intervention

In a recent meta-analysis, recurrent dislocation and instability occurred at a rate of 52.9% following nonsurgical treatment.² The decision to perform surgical intervention is typically made following failure of conservative management. Other considerations include age, gender, bone loss, and cartilage defect.^21,22 Age younger than 30 years, participation in competition, contact sports, and male gender have been associated with an increased risk of recurrence.^23-25 For this reason, obtaining an MRI at time of first dislocation can help facilitate surgical decisions if the patient is at high risk for surgical need.²⁶

Continue to: An increasing number...

An increasing number of dislocations portends a poor outcome with nonoperative treatment. Kao et al demonstrated a second dislocation leads to another dislocation in 19.6% of cases, while 44.3% of those with a third dislocation event will sustain another dislocation.²⁴ Surgery should be considered for patients with recurrent instability events to prevent persistent instability and decrease the amount of bone loss that can occur with repetitive dislocations.

What are the surgical options?

Several surgical options exist to remedy the unstable shoulder. Procedures can range from an arthroscopic repair to an open stabilization combined with structural bone graft to replace a bone defect caused by repetitive dislocations.

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.²¹ These techniques cause less pain in the early postoperative period and provide for a faster return to work.²⁷ Arthroscopy has the additional advantage of allowing for complete visualization of the glenohumeral joint to identify and address concomitant pathology, such as intra-articular loose bodies or rotator cuff tears.

Open repair was the mainstay of treatment prior to development of arthroscopic techniques. Some surgeons still prefer this method—especially in high-risk groups—because of a lower risk of recurrent disloca-tion.²⁸ Open techniques often involve detachment and repair of the upper subscapularis tendon and are more likely to produce long-term losses in external rotation range of motion.²⁸

Which one is appropriate for your patient? The decision to pursue an open or arthroscopic procedure and to augment with bone graft depends on the amount of glenoid and humeral head bone loss, patient activity level, risk of recurrent dislocation, and surgeon preference.

Continue to: For the nonathletic population...

For the nonathletic population, the timing of injury is less critical and surgery is typically recommended after conservative treatment has failed. In an athletic population, the timing of injury is a necessary consideration. An injury midseason may be “rehabbed” in hopes of returning to play. Individuals with injuries occurring at the end of a season, who are unable to regain desired function, and/or with peri-articular fractures or associated full-thickness rotator cuff tears may benefit from sooner surgical intervention.²¹

Arthroscopic techniques have become the mainstay of treatment and account for 71% of stabilization procedures performed.

Owens et al have described appropriate surgical indications and recommendations for an in-season athlete.²¹ In this particular algorithm, the authors suggest obtaining an MRI for decision making, but this is specific to in-season athletes wishing to return to play. In general, an MRI is not always indicated for patients who wish to receive conservative therapy but would be indicated for surgical considerations. The algorithm otherwise uses bone and soft-tissue injury, recurrent instability, and timing in the season to help determine management.²¹

Outcomes: Surgery has advantages …

Recurrence rates following surgical intervention are considerably lower than with conservative management, especially among young, active individuals. A recent systematic review by Donohue et al demonstrated recurrent instability rates following surgical intervention as low as 2.4%.²⁹ One study comparing the outcome of arthroscopic repair vs conservative management showed that the risk of postoperative instability was reduced by 20% compared to other treatments.⁷ Furthermore, early surgical fixation can improve quality of life, produce better functional outcomes, decrease time away from activity, increase patient satisfaction, and slow the development of glenohumeral osteoarthritis produced from recurrent instability.^2,7

Complications. Surgery does carry inherent risks of infection, anesthesia effects, surgical complications, and surgical failure. Recurrent instability is the most common complication following surgical shoulder stabilization. Rates of recurrent instability after surgical stabilization depend on patient age, activity level, and amount of bone loss: males younger than 18 years who participate in contact competitive sports and have significant bone loss are more likely to have recurrent dislocation after surgery.²³ The type of surgical procedure selected may decrease this risk.

While the open procedures decrease risk of postoperative instability, these surgeries can pose a significant risk of complications. Major complications for specific open techniques have been reported in up to 30% of patients³⁰ and are associated with lower levels of surgeon experience.³¹ While the healing of bones and ligaments is always a concern, 1 of the most feared complications following stabilization surgery is iatrogenic nerve injury. Because of the axillary nerve’s close proximity to the inferior glenoid, this nerve can be injured without meticulous care and can result in paralysis of the deltoid muscle. This injury poses a major impediment to normal shoulder function. Some procedures may cause nerve injuries in up to 10% of patients, although most injuries are transient.³²

Continue to: Bottom line

Due to the void of evidence-based guidelines for conservative vs surgical management of primary shoulder dislocation, it would be prudent to have a risk-benefit discussion with patients regarding treatment options.

Patients older than 30 years and those with uncomplicated injuries are best suited for conservative management of primary shoulder dislocations. Immobilization is debated and may not change outcomes, but a progressive rehabilitative program after the initial acute injury is helpful. Risk factors for failing conservative management include recurrent dislocation, subsequent arthropathy, and additional concomitant bone or soft-­tissue injuries.

Patients younger than 30 years who have complicated injuries with bone or cartilage loss, rotator cuff tears, or recurrent instability, and highly physically active individuals are best suited for surgical management. Shoulder arthroscopy has become the mainstay of surgical treatment for shoulder dislocations. Outcomes are favorable and dislocation recurrence is low after surgical repair. Surgery does carry its own inherent risks of infection, anesthesia effects, complications during surgery, and surgical failure leading to recurrent instability.

CORRESPONDENCE
Cayce Onks, DO, MS, ATC, Penn State Hershey, Milton S. Hershey Medical Center, Penn State College of Medicine, Family and Community Medicine H154, 500 University Drive, PO Box 850, Hershey, PA 17033-0850; [email protected]

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

CASE

John D,* a 25-year-old patient with an otherwise unremarkable medical history, describes 2 months of daily headache, lower-extremity weakness, and unsteady gait that began fairly suddenly during his first deployment in the US Army. He explains that these symptoms affected his ability to perform his duties and necessitated an early return stateside for evaluation and treatment.

Mr. D denies precipitating trauma or unusual environmental exposures. He reports that, stateside now, symptoms continue to affect his ability to work and attend to personal and family responsibilities.

Asked about stressors, Mr. D notes the birth of his first child approximately 3 months ago, while he was deployed, and marital stressors. He denies suicidal or homicidal ideation.

* The patient’s name has been changed to protect his identity.

The challenge of identifying and managing FND

A functional neurological disorder (FND) is a constellation of psychological, physiological, and neurological symptoms, without an identifiable organic etiology, a conscious decision, or secondary gain for the patient,¹ that adversely impacts functioning in 1 or more significant life domains.

Given the high throughput of patients in primary care practices, family physicians can expect to encounter suspected cases of FND in their practices. Regrettably, however, a lack of familiarity with the disorder and its related problems (eg, nonorganic paralysis, sensory loss, nonepileptic seizures, and abnormal movements) can add as much as $20,000 in excess direct and indirect costs of care for every such patient.¹ In this article, we synthesize the recent literature on FND so that family physicians can expand their acumen in understanding, identifying, and evaluating patients whose presentation suggests FND.

An underrecognized entity

A precise estimate of the prevalence of FND is difficult to determine because the disorder is underrecognized and misdiagnosed and because it is often accompanied by the confounding of psychological and physiological comorbidities. A 2012 study estimated the annual incidence of FND to be 4 to 12 cases for every 100,000 people²; in primary care and outpatient neurology settings, prevalence is 6% to 22% of all patients.^3,4 Stone and colleagues identified functional neurological symptoms as the second most common reason for outpatient neurology consultation,⁵ with 1 nonepileptic seizure patient seen for every 6 epileptic patients, and functional weakness presenting at the same rate as multiple sclerosis.⁶

Continue to: Demographics of patients with FND...

Demographics of patients with FND vary, depending on presenting neurological symptoms and disorder subtype. Existing data indicate a correlation between FND and younger age, female sex, physical disability,⁷ and a history of abuse or trauma.^3,8 A challenge in concretely ascertaining the prevalence of FND is that conditions such as fibromyalgia, chronic pelvic pain, globus hystericus, and nonepileptic seizures can also be characterized as medically unexplained functional disorders, even within the network of neurology care.⁴

Misdiagnosis and bias are not uncommon

Ambiguity in classifying and evaluating FND can affect physicians’ perceptions, assessment, and care of patients with suggestive presenting symptoms. A major early challenge in diagnosing FND is the inconsistency of characterizing terminology (pseudoneurological, somatic, dissociative, conversion, psychogenic, hysterical, factitious, functional, medically unexplained^9,10) and definitions in the literature. Neurological symptoms of unidentifiable organic cause can greatly diminish quality of life⁴; FND is a scientifically and clinically useful diagnosis for many combinations of nonrandomly co-occurring symptoms and clinical signs.

The pitfall of misdiagnosis. Remain cautious about making a diagnosis of FND by exclusion, which might yield an incorrect or false-negative finding because of an atypical presentation. It is important to avoid misdiagnosis by prematurely closing the differential diagnosis; instead, keep in mind that a medically unexplained diagnosis might be better explained by conducting a robust social and medical history and obtaining additional or collateral data, or both, along with appropriate consultation.^4,9

Remain cautious about making a diagnosis of FND by exclusion; an atypical presentation might lead to an incorrect or false-negative finding.

Misdiagnosis can lead to a circuitous and costly work-up, with the potential to increase the patient’s distress. You can reduce this burden with early recognition of FND and centralized management of multidisciplinary care, which are more likely to lead to an accurate and timely diagnosis—paramount to empowering patients with access to the correct information and meaningful support needed to enhance treatment and self-care.⁹

Bias, haste, and dismissal are unproductive. Even with a clear definition of FND, it is not uncommon for a physician to rapidly assess a patient’s clinical signs, make a diagnosis of “unknown etiology,” or openly question the veracity of complaints. Furthermore, be aware of inadvertently characterizing FND using the prefix “pseudo” or the term “hysterical,” which can be psychologically discomforting for many patients, who legitimately experience inexplicable symptoms. Such pejoratives can lead to stigmatizing and misleading assessments and treatment paths⁴—courses of action that can cause early and, possibly, irreparable harm to the patient–physician relationship and increase the patient’s inclination to go “doctor-shopping,” with associated loss of continuity of care.

Why is it difficult to diagnose FND?

The latest (5th) edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) describes conversion, somatoform disorder, and FND synonymously.DSM-5 diagnostic criteria for conversion disorderare¹¹:

• a specified type of symptom or deficit of altered voluntary motor or sensory function (eg, weakness, difficulty swallowing, slurred speech, seizures)
• clinical evidence of the incompatibility of the symptom or deficit and any recognized neurological or medical disorder
• incapability of better explaining the symptom or deficit as another medical or mental disorder.
• The symptom or deficit causes distress or impairment that (1) is clinically significant in occupational, social, or other important areas of function or (2) warrants medical evaluation.

The overarching feature of these criteria is the inconsistency of symptoms with recognized neurological, physiological, or psychiatric conditions. Although identification of psychological factors can help clarify and provide a treatment direction, such identification is not essential for making a diagnosis of FND. Malingering does not need to be refuted as part of establishing the diagnosis.¹²

Continue to: In contrast...

In contrast, the World Health Organization’s ICD-10 Classification of Mental and Behavioural Disorders groups diagnostic criteria for FND among the dissociative disorders¹³:

• Clinical features are specified for the individual dissociative disorder (motor, sensory, convulsions, mixed).
• Evidence is absent of a physical disorder that might explain symptoms.
• Evidence of psychological causation is present in clear temporal association with stressful events and problems or disturbed relationships, even if the patient denies such association.

Note the emphasis on psychological causation and exclusion of purposeful simulation of symptoms, as opposed to a primarily unconscious disconnection from the patient’s body or environment.

ICD-10 guidelines acknowledge the difficulty of finding definitive evidence of a psychological cause and recommend provisional diagnosis of FND if psychological factors are not readily apparent.¹⁴ Of note, many patients with FND are affected psychologically by their condition, with an impact on mood, behaviors, and interpersonal interactions, although not necessarily to a clinically diagnostic degree. Therefore, a psychiatric diagnosis alone is not a necessary precursor for the diagnosis of an FND.

CASE 

History. Mr. D’s history is positive for light alcohol consumption (“2 or 3 cans of beer on weekends”) and chewing tobacco (he reports stopping 6 months earlier) and negative for substance abuse. The family history is positive for maternal hypertension and paternal suicide when the patient was 10 years old (no other known paternal history).

Physical findings. The review of systems is positive for intermittent palpitations, lower-extremity weakness causing unsteady gait, and generalized headache.

Ask the patient to list all of his or her symptoms at the beginning of the interview; this can help elucidate a complex or ambiguous presentation.

Vital signs are within normal limits, including blood pressure (120/82 mm Hg) and heart rate (110 beats/min). The patient is not in acute distress; he is awake, alert, and oriented × 3. No murmurs are heard; lungs are clear bilaterally to auscultation. There is no tenderness on abdominal palpation, and no hepatomegaly or splenomegaly; bowel sounds are normal. No significant bruising or lacerations are noted.

Neurology exam. Cranial nerves II-XII are intact. Pupils are equal and reactive to light. Reflexes are 2+ bilaterally. Muscle strength and tone are normal; no tremors are noted. Babinski signs are normal. A Romberg test is positive (swaying).

Continue to: Mr. D has an antalgic gait...

Mr. D has an antalgic gait with significant swaying (without falling); bent posture; and unsteadiness that requires a cane. However, he is able to get up and off the exam table without assistance, and to propel himself, by rolling a chair forward and backward, without difficulty.

Conducting a diagnostic examination

Taking the history. Certain clues can aid in the diagnosis of FND (TABLE 1).¹⁵ For example, the patient might have been seen in multiple specialty practices for a multitude of vague symptoms indicative of potentially related conditions (eg, chronic fatigue, allergies and sensitivities, fibromyalgia, and other chronic pain). The history might include repeated surgeries to investigate those symptoms (eg, laparoscopy, or hysterectomy at an early age). Taking time and care to explore all clinical clues, patient reports, and collateral data are therefore key to making an accurate diagnosis.

A coexisting psychiatric diagnosis might be associated with distress from the presenting functional neurological symptoms—not linked to the FND diagnosis itself.

Note any discrepancies between the severity of reported symptoms and functional ability. A technique that can help elucidate a complex or ambiguous medical presentation is to ask the patient to list all their symptoms at the beginning of the interview. This has threefold benefit: You get a broad picture of the problem; the patient is unburdened of their concerns and experiences your validation; and a long list of symptoms can be an early clue to a diagnosis of FND.

Other helpful questions to determine the impact of symptoms on the patient’s well-­being include inquiries about¹⁶:

• functional impairment
• onset and course of symptoms
• potential causal or correlating events
• dissociative episodes
• previous diagnoses and treatments
• the patient’s perceptions of, and emotional response to, their illness
• a history of abuse.

The physical examination to determine the presence of FND varies, depending on the functional area of impact (eg, motor, neurological, sensory, speech and swallowing). Pay particular attention to presenting signs and clues, and balance them with the patient’s report (or lack of report). Endeavor to demonstrate positive functional signs, such as a positive Hoover test, which relies on the principle of synergistic muscle contraction. You might see evidence of inconsistency, such as weakness or a change in gait, under observation, that seemingly resolves when the patient is getting on and off the exam table.¹⁶Table 2^15-24 describes areas affected by FND, characteristics of the disorder, and related diagnostic examinations.

Table 3^15,18,19 reviews validated special exams that can aid in making the diagnosis. Additional special tests are discussed in the literature.^15-24 These tests can be helpful in narrowing the differential diagnosis but have not been validated and should be used with caution.

Some clinical signs associated with FND might be affected by other factors, including socioeconomic status, limited access to health care, low health literacy, poor communication skills, and physician bias. Keep these factors in mind during the visit, to avoid contributing further to health disparities among groups of patients affected by these problems.

Continue to: CASE

CASE 

The work-up over the next month for Mr. D includes numerous studies, all yielding results that are negative or within normal limits: visual acuity; electrocardiography and an event monitor; laboratory testing (including a complete blood count, comprehensive metabolic panel, thyroid-stimulating hormone, creatine kinase, erythrocyte sedimentation rate, C-­reactive protein, vitamin B₁₂, folate, and vitamin D); magnetic resonance imaging of the brain and lumbar spine; lumbar puncture; and electromyography.

The score on the 9-item Patient Health Questionnaire for depression is 4 (severity: “none or minimal”); on the 7-item Generalized Anxiety Disorder scale, 0 (“no anxiety disorder”).

Referral. A neurology work-up of headache, lower extremity weakness, and unsteady gait to address several diagnostic possibilities, including migraine and multiple sclerosis, is within normal limits. A cardiology work-up of palpitations is negative for arrhythmias and other concerning findings.

Mr. D declines psychiatric and psychological evaluations.

Building a differential diagnosisis a formidable task

The differential diagnosis of FND is vast. It includes neurological, physiological, and psychiatric symptoms and disorders; somatization; and malingering (Table 4).⁶ Any disorder or condition in these areas that is in the differential diagnosis can be precipitated or exacerbated by stress; most, however, do not involve loss of physical function.¹² In addition, the diagnosis of an FND does not necessarily exclude an organic disorder.

A patient’s presentation becomes complicated—and more difficult to treat—when functional symptoms and an unrelated underlying or early-stage neurological condition coexist. For example, a patient with epilepsy might also have dissociative seizures atop their organic disorder. Neurological disease is considered a risk factor for an overlying FND—just as the risk of depression or anxiety runs concurrently with other chronic diseases.¹⁴

Focus on clinical signs to narrow the differential. A thorough social and medical history and physical examination, as discussed earlier, help narrow the differential diagnosis of organic and medically unexplained disorders. Well-defined imaging or laboratory protocols do not exist to guide physicians to a definitive diagnosis, however.

Continue to: Psychiatric conditions

Psychiatric conditions can coexist with the diagnosis of FND, but might be unrelated. A systematic review of the literature showed that 17% to 42% of patients with FND had a concurrent anxiety disorder. Depression disorders were co-diagnosed in 19% to 71% of patients with FND; dissociative and personality disorders were noted, as well.²⁵ However, coexisting psychiatric diagnosis might more likely be associated with distress from the presenting functional neurological symptoms, not linked to the FND diagnosis itself.¹² This shift in understanding is reflected in the description of FND in the DSM-5.¹¹

CASE

Mr. D reports debilitating headaches at return office visits. Trials of abortive triptans provide no relief; neither do control medications (beta-blockers, coenzyme Q10, magnesium, onabotulinumtoxinA [Botox], topiramate, and valproate). Lower-extremity weakness and unsteadiness are managed with supportive devices, including a cane, and physical therapy.

Importance of establishing a multidisciplinary approach

The complexity of FND lends itself to a multidisciplinary approach during evaluation and, eventually, for treatment. The assessment and diagnostic intervention that you provide, along with the contributions of consulted specialists (including neurology, physical and occupational therapy, psychiatry, psychology, and other mental health professionals) establishes a team-based approach that can increase the patient’s sense of support and reduce excessive testing and unnecessary medications, surgeries, and other treatments.²⁶

Family physicians are in the ideal position to recognize the patient’s functional capacity and the quality of symptoms and to provide timely referral (eg, to Neurology and Psychiatry) for confirmation of the diagnosis and then treatment.

Evidence-based treatment options include:

• psychotherapy, with an emphasis on cognitive behavioral therapy
• physical therapy
• psychopharmacology
• promising combinations of physical and psychological treatment to improve long-term functionality.²⁷

A promising diagnostic tool

The most significant update in the FND literature is on functional neuroimaging for assessing the disorder. Early findings suggest an intricate relationship between mind and body regarding the pathological distortion in FND. And, there is clear evidence that neuroimaging—specifically, functional magnetic resonance imaging—shows changes in brain activity that correspond to the patient’s symptom report. That said, imaging is not the recommended standard of care in the initial work-up of FND because of its cost and the fact that the diagnosis is principally a clinical undertaking.^17,28

Call to action

Offer a generous ear. Begin the diagnostic pursuit by listening carefully and fully to the patient’s complaints, without arriving at a diagnosis with unwarranted bias or haste. This endeavor might require support from other clinical staff (eg, nurses, social workers, case managers) because the diagnostic process can be arduous and lengthy.

Continue to: Convey the diagnosis with sensitivity

Convey the diagnosis with sensitivity. Inquire about the patient’s perceptions and impairments to best personalize your diagnostic explanations. Delivery of the diagnosis might affect the patient’s acceptance and compliance with further testing and treatment of what is generally a persistent and treatment-resistant disorder; poor delivery of diagnostic information can impair the patient–physician relationship and increase the risk of disjointed care. Many patients find that improved patient–­physician communication is therapeutic.²⁹

Let the patient know that you’re taking her seriously. Validate patient concerns with a nonstigmatizing diagnostic label; discuss the diagnostic parameters and cause of symptoms in layman’s terms; and emphasize the potential for reversibility.³⁰ Some patients are not satisfied with having a diagnosis of FND until they are reassured with normal results of testing and provided with referral; even then, some seek further reassurance.

Key tenets of managing care for patients who have been given a diagnosis of FND include:

• nonjudgmental, positive regard
• meaningful expression of empathy
• multidisciplinary coordination
• avoidance of unnecessary testing and harmful treatments
• descriptive and contextual explanations of the diagnosis.

There is clear evidence that functional magnetic resonance imaging reveals changes in brain activity that correspond with the report of symptoms.

Last, keep in mind that the course of treatment for FND is potentially prolonged and multilayered.

CASE

After many visits with his family physician and the neurology and cardiology specialists, as well as an extensive work-up, the physician approaches Mr. D with the possibility of a diagnosis of FND and proposes a multidisciplinary plan that includes:

• a course of physical and occupational therapy
• development of individualized cognitive behavioral tools
• weekly personal and marital counseling
• initiation of a selective serotonin reuptake inhibitor for anxiety
• monthly visits with his family physician.

Months after his return from deployment for evaluation and treatment, Mr. D is able to return to military duty. He reports that his quality of life has improved.

CORRESPONDENCE
Roselyn W. Clemente Fuentes, MD, FAAFP, Eglin Family Medicine Residency, 307 Boatner Road, Eglin AFB, FL 32547; [email protected].

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

A version of this article first appeared on Medscape.com.

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

A version of this article first appeared on Medscape.com.

With chronic pain common among people with multiple sclerosis (MS), approximately 20% of patients report opioid use - despite warnings that the drugs are generally not recommended for the management of chronic pain and ongoing concerns of addiction, new research shows.

“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.

With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.

Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.

Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).

There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.

“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”

Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”

But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”

A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.

Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.

Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”

“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
 

Stretching program for spasticity shows benefits

With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).

Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.

In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.

The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).

Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.

“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.

“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.

Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.

A version of this article first appeared on Medscape.com.