Training in Back Care to Improve Outcome and Patient Satisfaction Teaching Old Docs New Tricks

Alternative or complementary approaches to medical care are gaining loyalty from patients and increasing interest from the allopathic health care community.^1-4 In particular, professional organizations in the areas of acupuncture and manual therapy are offering and expanding continuing medical education (CME) programs in these fields for allopathic physicians, though there are few published data on their effectiveness.^5,6

The direct impact of CME on patients and clinical practice has been little studied, particularly in relation to the treatment of low back pain.⁷ Cherkin and colleagues^8,9 undertook an evaluation of a didactic CME program on low back pain in 1991 by studying patient satisfaction and provider attitudes. It appeared that the patients of providers who professed greater confidence in managing low back pain were more satisfied with their care, though negative attitudes previously expressed by clinicians toward low back pain did not change significantly after CME. In a discussion of this study it was suggested that patients might be seeking information and practical guidance rather than a cure or empathy.¹⁰ However, the investigators did not study the effects of modifying physical examination and manual skills in the care of these patients, factors that might play an important role in outcomes.

Although greater patient satisfaction has been associated with chiropractic care (which emphasizes manual skills) than that given by primary care physicians, there appears to be no association of satisfaction with practitioner self-confidence or days to functional recovery of the patient.^11,12

We developed a workshop for generalist clinicians in the skills of assessment, limited manual therapy, and a graded exercise program, and in a randomized controlled trial evaluated clinician self-efficacy and patient outcomes for acute low back pain.^13,14 We demonstrated that allopathic generalist physicians could be effectively trained in limited manual therapy with self-reported increased competence in managing low back pain. The patients receiving therapy showed a trend toward feeling completely better more quickly but reported no greater satisfaction or objective functional improvement in terms of activities than patients in the control group who were receiving only high-quality conventional care through workshop training.¹⁴

Of 31 physicians recruited into the manual therapy trial, 13 had previously been involved in a cohort study of utilization and back care therapy given by 208 practitioners (115 primary care generalists) to 1633 patients (644 patients of primary care generalists).¹¹ We examined the outcomes of patients with low back pain from the practices of these 13 physicians before (data from the cohort study) and after an intensive hands-on training workshop (data from the manual therapy trial), using similar patient recruitment methods and evaluation instruments ([Figure 1]. Our hypothesis was that this training in manual and assessment skills would improve patient outcomes and satisfaction.

Methods

The initial cohort study was undertaken to examine the prevalence, care seeking, and outcomes of acute low back pain in the state of North Carolina. No interventions were undertaken in this study. Methods and measures used in its implementation have been described previously by Carey and coworkers.¹¹ Clinicians were randomly selected from medical and chiropractic licensure files (primary care generalists, chiropractic physicians, and orthopedic surgeons). To be included in the cohort study clinicians had to see ambulatory patients at least 50% of the time and provide first contact care for acute low back pain. Of the 208 clinicians from different disciplines recruited into the study, 115 were primary care physicians. During a 10-month period consecutive patients with acute or subacute low back pain (<10 weeks) were enrolled unless they had received previous care for the episode, had received previous back surgery, had a history of cancer, were pregnant, had no telephone, or were unable to speak English. Patients were contacted by telephone after the visit by staff members of the University of North Carolina Survey Research Unit, and interviews were undertaken at baseline, 2, 4, 8, 12, and 24 weeks.

These interviews included questions about details of the back pain episode, medications and other therapies used, tests performed, work and compensation status, demographic data, and income level. Outcome data included responses to the 23-item Roland-Morris Back Disability Questionnaire.¹⁵ We also asked when the patients considered they were able to perform their usual daily activities after the back pain. Patient satisfaction was assessed on how well the physician communicated, listened, gave information and explained the cause of back pain, whether a detailed history was taken and the back examined carefully, and if advice was given on pain management, prevention, and activities of sleeping and sitting (yes/no responses). Other satisfaction items (overall treatment, pain relief provided, and patient abilities to walk, socialize, and work) were rated on a 5-point Likert scale (poor, fair, good, very good, or excellent). This was subsequently adapted to a dichotomous response. Clinical and utilization data were obtained from charts in the physicians’ offices to allow validation of survey variables.

The randomized trial of the effectiveness of limited manual therapy was started in 1995, 12 months after the closure of the cohort study. Patients were recruited by 31 generalist physicians (13 from the earlier cohort study and 18 volunteers from the 630 physicians on the North Carolina physician master file). The same inclusion and exclusion criteria from the cohort study were used except that the acceptable age range was 21 to 65 (compared with 75 years) and patients had no osteopenia, severe arthritis, morbid obesity, or neurological deficits and had not received previous manual therapy by the physician. These additional exclusion criteria were necessary to avoid possible adverse effects of manual therapy in the presence of disease and to eliminate patient bias of a preference for manual therapy based on previous experience.

For each arm of the study, after the first office visit the identical telephone interview questions and schedule used in the cohort study were implemented for up to 8 weeks. Chart abstraction methods and variables were also identical except that additional data were collected on the specifics of manual therapy given at each visit.

Two sequential weekend workshops with a refresher session for each of the 31 physicians (developed and given to 9 physicians per workshop by 3 family physicians skilled in manual therapy) were implemented before the start of the clinical trial. The purpose was to train these physicians in quality care for low back pain (explained to patients as enhanced care—the control arm) and in standardized limited manual therapy (the main component of the intervention arm).¹³ The term “enhanced care” was developed to minimize the impression for patients during randomization that they might either receive something special (manual therapy) or just routine care—both options needed to appear to be special to reduce placebo bias.

Training for the enhanced low back pain care arm included physician education in (1) the directed history and physical examination using Agency for Health Care Policy and Research (AHCPR) guidelines,¹⁶ (2) review of the efficacy of imaging and laboratory testing, (3) review of the efficacy of treatment modalities, and (4) use of specially designed patient handouts emphasizing progressive exercises, daily activities, and early return to function.

Training for the limited manual therapy arm included the enhanced low back pain skills plus:

• manual therapy, consisting of: (1) principles of manual therapy and explanatory models, (2) instruction in motion testing, and (3) instruction in limited manual therapy skills (soft-tissue, muscle energy, and high-velocity low-amplitude techniques involving psoas and piriformis muscles—lumbar spine, lumbosacral junction, and sacroiliac joints)
• workshop training and demonstrated competence in low back care on simulated patients
• guidance and practice in integrating limited manual therapy into the office visit
• education and practice in recruiting patients and in the procedures of random assignment of those patients to the control (enhanced care) arm or the manual therapy arm

After training, the physicians returned to their practices and worked on their newly learned skill for approximately 3 months before enrolling patients. At an agreed time they began to enroll patients and randomized them to enhanced care or enhanced care plus limited manual therapy using a blinded method.

Analysis

Using the patients of the 13 physicians active in both the original cohort study and the subsequent randomized trial of limited manual therapy, we compared outcomes between 3 groups of patients: (1) those whose usual care was only observed in the earlier cohort study, (2) those receiving enhanced care (control arm) in the randomized trial, and (3) those receiving enhanced care plus manual therapy (intervention arm) in the randomized trial. The major variables included in the analyses were age, sex, education, household income, duration of low back pain episode for more than 2 weeks, presence of sciatica, workers’ compensation status, and the Work Adaptation, Partnership, Growth, Affection, and Resolve Survey (a measure of job satisfaction).¹⁶ In each of the studies, outcome measures from repeated interviews included data on functional status over time and pain levels. Data on satisfaction with care, return to work, and time to functional and complete recovery were obtained either at 8 weeks or when the patients were better. The main outcome measures were the Roland-Morris adaptation of the Sickness Impact Profile (a 23-item scale with high scores indicating significant dysfunction), patients’ report of being all better or functionally better, and the date they were able to return to performing their usual daily activities.^10,14 Patient satisfaction measures were based on the scale developed by Cherkin and colleagues.⁸ The patient was the unit of analysis.

Pearson’s chi-square was used when comparing the 3 patient groups by physician performance and patient satisfaction, adjusting for baseline differences. Linear modeling was used to examine the relationship of manual therapy to functional status (Roland-Morris score). Cox proportional hazard modeling was undertaken to identify survival curves of time to functional recovery. In all analyses, standard errors were corrected for any intraclass correlation due to nonindependence of patients seeing the same physician.¹⁷

Results

The 13 physicians cared for 120 patients in the observational study and 191 patients in the randomized trial [Figure 1]. In each of the studies very similar numbers of patients were seen by each physician. Within the 2 arms of the randomized trial of manual therapy, baseline characteristics were essentially the same [Table 1].

There were some differences in baseline characteristics between patients in the cohort study and the randomized trial. More patients in the randomized trial (41.4% vs 25%, P=.01) had significantly higher severe baseline dysfunction (Roland-Morris score=16-23) than in the cohort study. The mean baseline Roland Morris score was 10.0 for the cohort study patients compared with 12.5 for the manual therapy study patients (P=.03). There were more patients on workers’ compensation in the cohort study (35%) than in the manual therapy study (16.3%, P=.002), and fewer had been employed in the previous 3 months (80.8% vs 90.0%, P=.02).

Patients in both arms of the randomized manual therapy trial were significantly more satisfied than their counterparts in the earlier cohort study in terms of how their physician gave care in the clinical encounter and whether they received effective advice [Table 2]. Patients participating in the manual therapy trial were also more satisfied with their pain relief, their physicians’ overall treatment of back pain, and their ability to perform activities of daily living. Specific items of clinical performance where differences were noted included: the physician took a detailed history; gave useful advice on pain, preventive measures, sleeping, and sitting strategies; and provided back exercises. There were no differences in patient ratings of the physician’s ability to listen effectively, perform a careful physical examination, and explain the cause of their back pain. There were no differences in general health status between the cohort and manual therapy study patients.

When adjusted for baseline function, the presence of sciatica, duration of pain, employment status, workers’ compensation, and income of more than $20,000, mean functional outcomes measured by Roland-Morris scores at 2 weeks were 8.2 for the patients in the cohort study and 6.7 in the manual therapy trial (P=.03); at 4 weeks mean scores were 7.2 for the cohort and 5.2 for patients in the manual therapy trial (P=.02), and at 8 weeks scores were 6.7 and 3.6, respectively (P=.002). These were clinically significant differences showing that all patients in the clinical trial had lower functional disability levels during an 8-week period than patients of the same physicians in the cohort study.

After controlling for baseline Roland-Morris score, duration of low back pain, sciatica, employment status, workers’ compensation, and income more than $20,000, time to functional recovery reported by the patient (using Cox proportional hazard modeling) between the 3 groups of patients was as follows: (1) manual therapy + enhanced care versus cohort: hazard ratio (HR)=1.16; 95% confidence interval (CI), 0.85-1.58; (2) enhanced care alone versus cohort: HR=1.13; 95% CI, 0.82-1.54; and (3) manual therapy + enhanced care versus enhanced care alone: HR=1.03; 95% CI, 0.75-1.40. None of these HRs were significant [Figure 2].

Discussion

Data from patients of 13 physicians involved in an observational study of back care, followed by a randomized trial of the effect of additional clinical skills developed by hands-on training, provide an unusual opportunity to study patient outcomes and physician performance over time. Similar eligibility and exclusion criteria, data collection methods, and outcome measures were used in both studies, allowing us to directly compare the variables of interest.

After controlling for confounding factors and physician clustering effect, patients in the clinical trial of manual therapy had significantly more baseline dysfunction at the index visit but still recovered more rapidly by self-report. After workshop training for the physicians, the proportion of patients who reported effective evaluation and management of their back problem increased substantially.

There were no differences in the 2 studies in the proportions of patients reporting on how effectively their physician listened to them, explained causation, and discussed occupational issues. These latter activities were not specifically addressed in the training workshop, which concentrated on clinical evaluation, manual techniques, and issues of physical rehabilitation. One would expect that a general placebo effect on patients of the training would increase all parameters of their perceptions of care, so the workshop may have produced specific learning effects on the clinicians. Despite a trend favoring the group receiving care from the “trained” physicians, there were no significant differences in how patients perceived the quality of the physician’s physical examination of their back—an item that was particularly emphasized in the workshops. This aspect of physician performance was already highly rated in the cohort group and may have been less likely to show improvement, given the need to know what constitutes a superior examination technique.

The improved reported performances of physicians and patient outcomes were noted in both arms of the manual therapy trial, compared with those of patients in the earlier cohort study, though there was no difference in time to full functional recovery between the 2 studies. The inconsistency between outcomes (Roland-Morris scores and time to functional recovery) is probably explainable by the fact that they measure different patient perceptions of back problems—specific versus global recovery. This inconsistency of measures has been noted in other studies of low back pain interventions.¹⁸

The improved outcomes of patients in the randomized trial compared with those in the cohort may be because of specific elements of the study applicable to all patients or may have been due to unmeasured baseline differences. The patients in the randomized trial were more impaired at baseline, which would tend toward worse rather than better outcomes if severity was not completely controlled for. There are several possible explanations for these findings: (1) workshop training did improve physician knowledge and skills; (2) involvement of patients in a clinical trial in which an intervention (enhanced care) was given in both arms of the study (one also receiving manual therapy) could heighten the overall positive effect; (3) the clinical trial involved more visits (average=3.6) than with patients in the first study (1.3)—this could add significantly to patient satisfaction and perceptions of good care; and (4) the recruited physicians were a special group of interested and motivated individuals who by their nature would produce better outcomes in a clinical trial.

Limitations

There are limitations to our findings and conclusions. There were differences in exclusion criteria that might have reduced the number of unhealthy people recruited into the manual therapy trial compared with the cohort study. This could have led to better outcomes, though we doubt that these differences made much impact given the average age of the patients (40 years).

Although we adjusted for baseline differences (income, workers’ compensation, and employment status), we are not sure why these differences occurred. One possibility is that the rapid population and commercial growth and high employment rates that occurred in the state of North Carolina in the time between the 2 studies improved the economic characteristics of patients presenting to the physicians over time. It is also possible that patients with higher incomes and fewer employment difficulties would be more likely to rate physician communication and management more highly and improve more rapidly.

The global effect on clinician knowledge, skills, and performance of a 3-year span of evolving clinical practice and involvement in low back pain studies (other than participating in a training workshop) cannot be quantified. For example, improved performance and outcomes might have been related to the publication of the AHCPR back pain guidelines in 1994, approximately 6 months before the start of the manual therapy study.¹⁶ However, at the low back pain workshop (where only the AHCPR “red flags” were presented) the participants seemed to be only minimally aware of these guidelines.

If the improved outcomes noted in this study were mainly because of the passage of time rather than workshop training, this provides an interesting insight into how practice changes for the better.

Patient satisfaction with care has been shown to correlate with outcomes.^19,20 Deyo and Diehl suggested that dissatisfaction with care for low back pain was related to failure to obtain an adequate explanation from the physician, while Cherkin and colleagues proposed that lack of confidence in management and negative attitudes of clinicians might be key issues to be addressed in achieving better outcomes.^8-10,21,22 However, didactic training to remedy these problems did not appear to be very effective in improving satisfaction. Following up on these suggestions, Smucker and coworkers,¹² using the large North Carolina cohort study, showed that clinician self-confidence (allopathic and chiropractic physicians) did not predict patient outcomes but commented that communication, time spent with the patient, and manual evaluation and treatment skills might be important variables affecting outcome.¹²

The margin of differences in outcomes shown in our preintervention and postintervention analysis leads us to suggest that allopathic physicians using a brief systematic evaluation and hands-on regional physical examination, sound advice on pain management and prevention, and an increasingly active exercise program can modestly improve early patient functioning and satisfaction in acute low back pain. Whether training in limited manual therapy adds to this benefit is unclear and must be taken into account in relation to the current expansion of CME in manipulative skills for allopathic physicians. The costs and benefits of providing this training—with the possibility of needing one extra office visit or more to fully implement enhanced care—would need to be assessed.²³

Alternative or complementary approaches to medical care are gaining loyalty from patients and increasing interest from the allopathic health care community.^1-4 In particular, professional organizations in the areas of acupuncture and manual therapy are offering and expanding continuing medical education (CME) programs in these fields for allopathic physicians, though there are few published data on their effectiveness.^5,6

The direct impact of CME on patients and clinical practice has been little studied, particularly in relation to the treatment of low back pain.⁷ Cherkin and colleagues^8,9 undertook an evaluation of a didactic CME program on low back pain in 1991 by studying patient satisfaction and provider attitudes. It appeared that the patients of providers who professed greater confidence in managing low back pain were more satisfied with their care, though negative attitudes previously expressed by clinicians toward low back pain did not change significantly after CME. In a discussion of this study it was suggested that patients might be seeking information and practical guidance rather than a cure or empathy.¹⁰ However, the investigators did not study the effects of modifying physical examination and manual skills in the care of these patients, factors that might play an important role in outcomes.

Although greater patient satisfaction has been associated with chiropractic care (which emphasizes manual skills) than that given by primary care physicians, there appears to be no association of satisfaction with practitioner self-confidence or days to functional recovery of the patient.^11,12

We developed a workshop for generalist clinicians in the skills of assessment, limited manual therapy, and a graded exercise program, and in a randomized controlled trial evaluated clinician self-efficacy and patient outcomes for acute low back pain.^13,14 We demonstrated that allopathic generalist physicians could be effectively trained in limited manual therapy with self-reported increased competence in managing low back pain. The patients receiving therapy showed a trend toward feeling completely better more quickly but reported no greater satisfaction or objective functional improvement in terms of activities than patients in the control group who were receiving only high-quality conventional care through workshop training.¹⁴

Of 31 physicians recruited into the manual therapy trial, 13 had previously been involved in a cohort study of utilization and back care therapy given by 208 practitioners (115 primary care generalists) to 1633 patients (644 patients of primary care generalists).¹¹ We examined the outcomes of patients with low back pain from the practices of these 13 physicians before (data from the cohort study) and after an intensive hands-on training workshop (data from the manual therapy trial), using similar patient recruitment methods and evaluation instruments ([Figure 1]. Our hypothesis was that this training in manual and assessment skills would improve patient outcomes and satisfaction.

Methods

The initial cohort study was undertaken to examine the prevalence, care seeking, and outcomes of acute low back pain in the state of North Carolina. No interventions were undertaken in this study. Methods and measures used in its implementation have been described previously by Carey and coworkers.¹¹ Clinicians were randomly selected from medical and chiropractic licensure files (primary care generalists, chiropractic physicians, and orthopedic surgeons). To be included in the cohort study clinicians had to see ambulatory patients at least 50% of the time and provide first contact care for acute low back pain. Of the 208 clinicians from different disciplines recruited into the study, 115 were primary care physicians. During a 10-month period consecutive patients with acute or subacute low back pain (<10 weeks) were enrolled unless they had received previous care for the episode, had received previous back surgery, had a history of cancer, were pregnant, had no telephone, or were unable to speak English. Patients were contacted by telephone after the visit by staff members of the University of North Carolina Survey Research Unit, and interviews were undertaken at baseline, 2, 4, 8, 12, and 24 weeks.

These interviews included questions about details of the back pain episode, medications and other therapies used, tests performed, work and compensation status, demographic data, and income level. Outcome data included responses to the 23-item Roland-Morris Back Disability Questionnaire.¹⁵ We also asked when the patients considered they were able to perform their usual daily activities after the back pain. Patient satisfaction was assessed on how well the physician communicated, listened, gave information and explained the cause of back pain, whether a detailed history was taken and the back examined carefully, and if advice was given on pain management, prevention, and activities of sleeping and sitting (yes/no responses). Other satisfaction items (overall treatment, pain relief provided, and patient abilities to walk, socialize, and work) were rated on a 5-point Likert scale (poor, fair, good, very good, or excellent). This was subsequently adapted to a dichotomous response. Clinical and utilization data were obtained from charts in the physicians’ offices to allow validation of survey variables.

The randomized trial of the effectiveness of limited manual therapy was started in 1995, 12 months after the closure of the cohort study. Patients were recruited by 31 generalist physicians (13 from the earlier cohort study and 18 volunteers from the 630 physicians on the North Carolina physician master file). The same inclusion and exclusion criteria from the cohort study were used except that the acceptable age range was 21 to 65 (compared with 75 years) and patients had no osteopenia, severe arthritis, morbid obesity, or neurological deficits and had not received previous manual therapy by the physician. These additional exclusion criteria were necessary to avoid possible adverse effects of manual therapy in the presence of disease and to eliminate patient bias of a preference for manual therapy based on previous experience.

For each arm of the study, after the first office visit the identical telephone interview questions and schedule used in the cohort study were implemented for up to 8 weeks. Chart abstraction methods and variables were also identical except that additional data were collected on the specifics of manual therapy given at each visit.

Two sequential weekend workshops with a refresher session for each of the 31 physicians (developed and given to 9 physicians per workshop by 3 family physicians skilled in manual therapy) were implemented before the start of the clinical trial. The purpose was to train these physicians in quality care for low back pain (explained to patients as enhanced care—the control arm) and in standardized limited manual therapy (the main component of the intervention arm).¹³ The term “enhanced care” was developed to minimize the impression for patients during randomization that they might either receive something special (manual therapy) or just routine care—both options needed to appear to be special to reduce placebo bias.

Training for the enhanced low back pain care arm included physician education in (1) the directed history and physical examination using Agency for Health Care Policy and Research (AHCPR) guidelines,¹⁶ (2) review of the efficacy of imaging and laboratory testing, (3) review of the efficacy of treatment modalities, and (4) use of specially designed patient handouts emphasizing progressive exercises, daily activities, and early return to function.

Training for the limited manual therapy arm included the enhanced low back pain skills plus:

• manual therapy, consisting of: (1) principles of manual therapy and explanatory models, (2) instruction in motion testing, and (3) instruction in limited manual therapy skills (soft-tissue, muscle energy, and high-velocity low-amplitude techniques involving psoas and piriformis muscles—lumbar spine, lumbosacral junction, and sacroiliac joints)
• workshop training and demonstrated competence in low back care on simulated patients
• guidance and practice in integrating limited manual therapy into the office visit
• education and practice in recruiting patients and in the procedures of random assignment of those patients to the control (enhanced care) arm or the manual therapy arm

After training, the physicians returned to their practices and worked on their newly learned skill for approximately 3 months before enrolling patients. At an agreed time they began to enroll patients and randomized them to enhanced care or enhanced care plus limited manual therapy using a blinded method.

Analysis

Using the patients of the 13 physicians active in both the original cohort study and the subsequent randomized trial of limited manual therapy, we compared outcomes between 3 groups of patients: (1) those whose usual care was only observed in the earlier cohort study, (2) those receiving enhanced care (control arm) in the randomized trial, and (3) those receiving enhanced care plus manual therapy (intervention arm) in the randomized trial. The major variables included in the analyses were age, sex, education, household income, duration of low back pain episode for more than 2 weeks, presence of sciatica, workers’ compensation status, and the Work Adaptation, Partnership, Growth, Affection, and Resolve Survey (a measure of job satisfaction).¹⁶ In each of the studies, outcome measures from repeated interviews included data on functional status over time and pain levels. Data on satisfaction with care, return to work, and time to functional and complete recovery were obtained either at 8 weeks or when the patients were better. The main outcome measures were the Roland-Morris adaptation of the Sickness Impact Profile (a 23-item scale with high scores indicating significant dysfunction), patients’ report of being all better or functionally better, and the date they were able to return to performing their usual daily activities.^10,14 Patient satisfaction measures were based on the scale developed by Cherkin and colleagues.⁸ The patient was the unit of analysis.

Pearson’s chi-square was used when comparing the 3 patient groups by physician performance and patient satisfaction, adjusting for baseline differences. Linear modeling was used to examine the relationship of manual therapy to functional status (Roland-Morris score). Cox proportional hazard modeling was undertaken to identify survival curves of time to functional recovery. In all analyses, standard errors were corrected for any intraclass correlation due to nonindependence of patients seeing the same physician.¹⁷

Results

The 13 physicians cared for 120 patients in the observational study and 191 patients in the randomized trial [Figure 1]. In each of the studies very similar numbers of patients were seen by each physician. Within the 2 arms of the randomized trial of manual therapy, baseline characteristics were essentially the same [Table 1].

There were some differences in baseline characteristics between patients in the cohort study and the randomized trial. More patients in the randomized trial (41.4% vs 25%, P=.01) had significantly higher severe baseline dysfunction (Roland-Morris score=16-23) than in the cohort study. The mean baseline Roland Morris score was 10.0 for the cohort study patients compared with 12.5 for the manual therapy study patients (P=.03). There were more patients on workers’ compensation in the cohort study (35%) than in the manual therapy study (16.3%, P=.002), and fewer had been employed in the previous 3 months (80.8% vs 90.0%, P=.02).

Patients in both arms of the randomized manual therapy trial were significantly more satisfied than their counterparts in the earlier cohort study in terms of how their physician gave care in the clinical encounter and whether they received effective advice [Table 2]. Patients participating in the manual therapy trial were also more satisfied with their pain relief, their physicians’ overall treatment of back pain, and their ability to perform activities of daily living. Specific items of clinical performance where differences were noted included: the physician took a detailed history; gave useful advice on pain, preventive measures, sleeping, and sitting strategies; and provided back exercises. There were no differences in patient ratings of the physician’s ability to listen effectively, perform a careful physical examination, and explain the cause of their back pain. There were no differences in general health status between the cohort and manual therapy study patients.

When adjusted for baseline function, the presence of sciatica, duration of pain, employment status, workers’ compensation, and income of more than $20,000, mean functional outcomes measured by Roland-Morris scores at 2 weeks were 8.2 for the patients in the cohort study and 6.7 in the manual therapy trial (P=.03); at 4 weeks mean scores were 7.2 for the cohort and 5.2 for patients in the manual therapy trial (P=.02), and at 8 weeks scores were 6.7 and 3.6, respectively (P=.002). These were clinically significant differences showing that all patients in the clinical trial had lower functional disability levels during an 8-week period than patients of the same physicians in the cohort study.

After controlling for baseline Roland-Morris score, duration of low back pain, sciatica, employment status, workers’ compensation, and income more than $20,000, time to functional recovery reported by the patient (using Cox proportional hazard modeling) between the 3 groups of patients was as follows: (1) manual therapy + enhanced care versus cohort: hazard ratio (HR)=1.16; 95% confidence interval (CI), 0.85-1.58; (2) enhanced care alone versus cohort: HR=1.13; 95% CI, 0.82-1.54; and (3) manual therapy + enhanced care versus enhanced care alone: HR=1.03; 95% CI, 0.75-1.40. None of these HRs were significant [Figure 2].

Discussion

Data from patients of 13 physicians involved in an observational study of back care, followed by a randomized trial of the effect of additional clinical skills developed by hands-on training, provide an unusual opportunity to study patient outcomes and physician performance over time. Similar eligibility and exclusion criteria, data collection methods, and outcome measures were used in both studies, allowing us to directly compare the variables of interest.

After controlling for confounding factors and physician clustering effect, patients in the clinical trial of manual therapy had significantly more baseline dysfunction at the index visit but still recovered more rapidly by self-report. After workshop training for the physicians, the proportion of patients who reported effective evaluation and management of their back problem increased substantially.

There were no differences in the 2 studies in the proportions of patients reporting on how effectively their physician listened to them, explained causation, and discussed occupational issues. These latter activities were not specifically addressed in the training workshop, which concentrated on clinical evaluation, manual techniques, and issues of physical rehabilitation. One would expect that a general placebo effect on patients of the training would increase all parameters of their perceptions of care, so the workshop may have produced specific learning effects on the clinicians. Despite a trend favoring the group receiving care from the “trained” physicians, there were no significant differences in how patients perceived the quality of the physician’s physical examination of their back—an item that was particularly emphasized in the workshops. This aspect of physician performance was already highly rated in the cohort group and may have been less likely to show improvement, given the need to know what constitutes a superior examination technique.

The improved reported performances of physicians and patient outcomes were noted in both arms of the manual therapy trial, compared with those of patients in the earlier cohort study, though there was no difference in time to full functional recovery between the 2 studies. The inconsistency between outcomes (Roland-Morris scores and time to functional recovery) is probably explainable by the fact that they measure different patient perceptions of back problems—specific versus global recovery. This inconsistency of measures has been noted in other studies of low back pain interventions.¹⁸

The improved outcomes of patients in the randomized trial compared with those in the cohort may be because of specific elements of the study applicable to all patients or may have been due to unmeasured baseline differences. The patients in the randomized trial were more impaired at baseline, which would tend toward worse rather than better outcomes if severity was not completely controlled for. There are several possible explanations for these findings: (1) workshop training did improve physician knowledge and skills; (2) involvement of patients in a clinical trial in which an intervention (enhanced care) was given in both arms of the study (one also receiving manual therapy) could heighten the overall positive effect; (3) the clinical trial involved more visits (average=3.6) than with patients in the first study (1.3)—this could add significantly to patient satisfaction and perceptions of good care; and (4) the recruited physicians were a special group of interested and motivated individuals who by their nature would produce better outcomes in a clinical trial.

Limitations

There are limitations to our findings and conclusions. There were differences in exclusion criteria that might have reduced the number of unhealthy people recruited into the manual therapy trial compared with the cohort study. This could have led to better outcomes, though we doubt that these differences made much impact given the average age of the patients (40 years).

Although we adjusted for baseline differences (income, workers’ compensation, and employment status), we are not sure why these differences occurred. One possibility is that the rapid population and commercial growth and high employment rates that occurred in the state of North Carolina in the time between the 2 studies improved the economic characteristics of patients presenting to the physicians over time. It is also possible that patients with higher incomes and fewer employment difficulties would be more likely to rate physician communication and management more highly and improve more rapidly.

The global effect on clinician knowledge, skills, and performance of a 3-year span of evolving clinical practice and involvement in low back pain studies (other than participating in a training workshop) cannot be quantified. For example, improved performance and outcomes might have been related to the publication of the AHCPR back pain guidelines in 1994, approximately 6 months before the start of the manual therapy study.¹⁶ However, at the low back pain workshop (where only the AHCPR “red flags” were presented) the participants seemed to be only minimally aware of these guidelines.

If the improved outcomes noted in this study were mainly because of the passage of time rather than workshop training, this provides an interesting insight into how practice changes for the better.

Patient satisfaction with care has been shown to correlate with outcomes.^19,20 Deyo and Diehl suggested that dissatisfaction with care for low back pain was related to failure to obtain an adequate explanation from the physician, while Cherkin and colleagues proposed that lack of confidence in management and negative attitudes of clinicians might be key issues to be addressed in achieving better outcomes.^8-10,21,22 However, didactic training to remedy these problems did not appear to be very effective in improving satisfaction. Following up on these suggestions, Smucker and coworkers,¹² using the large North Carolina cohort study, showed that clinician self-confidence (allopathic and chiropractic physicians) did not predict patient outcomes but commented that communication, time spent with the patient, and manual evaluation and treatment skills might be important variables affecting outcome.¹²

The margin of differences in outcomes shown in our preintervention and postintervention analysis leads us to suggest that allopathic physicians using a brief systematic evaluation and hands-on regional physical examination, sound advice on pain management and prevention, and an increasingly active exercise program can modestly improve early patient functioning and satisfaction in acute low back pain. Whether training in limited manual therapy adds to this benefit is unclear and must be taken into account in relation to the current expansion of CME in manipulative skills for allopathic physicians. The costs and benefits of providing this training—with the possibility of needing one extra office visit or more to fully implement enhanced care—would need to be assessed.²³

Alternative or complementary approaches to medical care are gaining loyalty from patients and increasing interest from the allopathic health care community.^1-4 In particular, professional organizations in the areas of acupuncture and manual therapy are offering and expanding continuing medical education (CME) programs in these fields for allopathic physicians, though there are few published data on their effectiveness.^5,6

The direct impact of CME on patients and clinical practice has been little studied, particularly in relation to the treatment of low back pain.⁷ Cherkin and colleagues^8,9 undertook an evaluation of a didactic CME program on low back pain in 1991 by studying patient satisfaction and provider attitudes. It appeared that the patients of providers who professed greater confidence in managing low back pain were more satisfied with their care, though negative attitudes previously expressed by clinicians toward low back pain did not change significantly after CME. In a discussion of this study it was suggested that patients might be seeking information and practical guidance rather than a cure or empathy.¹⁰ However, the investigators did not study the effects of modifying physical examination and manual skills in the care of these patients, factors that might play an important role in outcomes.

Although greater patient satisfaction has been associated with chiropractic care (which emphasizes manual skills) than that given by primary care physicians, there appears to be no association of satisfaction with practitioner self-confidence or days to functional recovery of the patient.^11,12

We developed a workshop for generalist clinicians in the skills of assessment, limited manual therapy, and a graded exercise program, and in a randomized controlled trial evaluated clinician self-efficacy and patient outcomes for acute low back pain.^13,14 We demonstrated that allopathic generalist physicians could be effectively trained in limited manual therapy with self-reported increased competence in managing low back pain. The patients receiving therapy showed a trend toward feeling completely better more quickly but reported no greater satisfaction or objective functional improvement in terms of activities than patients in the control group who were receiving only high-quality conventional care through workshop training.¹⁴

Of 31 physicians recruited into the manual therapy trial, 13 had previously been involved in a cohort study of utilization and back care therapy given by 208 practitioners (115 primary care generalists) to 1633 patients (644 patients of primary care generalists).¹¹ We examined the outcomes of patients with low back pain from the practices of these 13 physicians before (data from the cohort study) and after an intensive hands-on training workshop (data from the manual therapy trial), using similar patient recruitment methods and evaluation instruments ([Figure 1]. Our hypothesis was that this training in manual and assessment skills would improve patient outcomes and satisfaction.

Methods

The initial cohort study was undertaken to examine the prevalence, care seeking, and outcomes of acute low back pain in the state of North Carolina. No interventions were undertaken in this study. Methods and measures used in its implementation have been described previously by Carey and coworkers.¹¹ Clinicians were randomly selected from medical and chiropractic licensure files (primary care generalists, chiropractic physicians, and orthopedic surgeons). To be included in the cohort study clinicians had to see ambulatory patients at least 50% of the time and provide first contact care for acute low back pain. Of the 208 clinicians from different disciplines recruited into the study, 115 were primary care physicians. During a 10-month period consecutive patients with acute or subacute low back pain (<10 weeks) were enrolled unless they had received previous care for the episode, had received previous back surgery, had a history of cancer, were pregnant, had no telephone, or were unable to speak English. Patients were contacted by telephone after the visit by staff members of the University of North Carolina Survey Research Unit, and interviews were undertaken at baseline, 2, 4, 8, 12, and 24 weeks.

These interviews included questions about details of the back pain episode, medications and other therapies used, tests performed, work and compensation status, demographic data, and income level. Outcome data included responses to the 23-item Roland-Morris Back Disability Questionnaire.¹⁵ We also asked when the patients considered they were able to perform their usual daily activities after the back pain. Patient satisfaction was assessed on how well the physician communicated, listened, gave information and explained the cause of back pain, whether a detailed history was taken and the back examined carefully, and if advice was given on pain management, prevention, and activities of sleeping and sitting (yes/no responses). Other satisfaction items (overall treatment, pain relief provided, and patient abilities to walk, socialize, and work) were rated on a 5-point Likert scale (poor, fair, good, very good, or excellent). This was subsequently adapted to a dichotomous response. Clinical and utilization data were obtained from charts in the physicians’ offices to allow validation of survey variables.

The randomized trial of the effectiveness of limited manual therapy was started in 1995, 12 months after the closure of the cohort study. Patients were recruited by 31 generalist physicians (13 from the earlier cohort study and 18 volunteers from the 630 physicians on the North Carolina physician master file). The same inclusion and exclusion criteria from the cohort study were used except that the acceptable age range was 21 to 65 (compared with 75 years) and patients had no osteopenia, severe arthritis, morbid obesity, or neurological deficits and had not received previous manual therapy by the physician. These additional exclusion criteria were necessary to avoid possible adverse effects of manual therapy in the presence of disease and to eliminate patient bias of a preference for manual therapy based on previous experience.

For each arm of the study, after the first office visit the identical telephone interview questions and schedule used in the cohort study were implemented for up to 8 weeks. Chart abstraction methods and variables were also identical except that additional data were collected on the specifics of manual therapy given at each visit.

Two sequential weekend workshops with a refresher session for each of the 31 physicians (developed and given to 9 physicians per workshop by 3 family physicians skilled in manual therapy) were implemented before the start of the clinical trial. The purpose was to train these physicians in quality care for low back pain (explained to patients as enhanced care—the control arm) and in standardized limited manual therapy (the main component of the intervention arm).¹³ The term “enhanced care” was developed to minimize the impression for patients during randomization that they might either receive something special (manual therapy) or just routine care—both options needed to appear to be special to reduce placebo bias.

Training for the enhanced low back pain care arm included physician education in (1) the directed history and physical examination using Agency for Health Care Policy and Research (AHCPR) guidelines,¹⁶ (2) review of the efficacy of imaging and laboratory testing, (3) review of the efficacy of treatment modalities, and (4) use of specially designed patient handouts emphasizing progressive exercises, daily activities, and early return to function.

Training for the limited manual therapy arm included the enhanced low back pain skills plus:

• manual therapy, consisting of: (1) principles of manual therapy and explanatory models, (2) instruction in motion testing, and (3) instruction in limited manual therapy skills (soft-tissue, muscle energy, and high-velocity low-amplitude techniques involving psoas and piriformis muscles—lumbar spine, lumbosacral junction, and sacroiliac joints)
• workshop training and demonstrated competence in low back care on simulated patients
• guidance and practice in integrating limited manual therapy into the office visit
• education and practice in recruiting patients and in the procedures of random assignment of those patients to the control (enhanced care) arm or the manual therapy arm

After training, the physicians returned to their practices and worked on their newly learned skill for approximately 3 months before enrolling patients. At an agreed time they began to enroll patients and randomized them to enhanced care or enhanced care plus limited manual therapy using a blinded method.

Analysis

Using the patients of the 13 physicians active in both the original cohort study and the subsequent randomized trial of limited manual therapy, we compared outcomes between 3 groups of patients: (1) those whose usual care was only observed in the earlier cohort study, (2) those receiving enhanced care (control arm) in the randomized trial, and (3) those receiving enhanced care plus manual therapy (intervention arm) in the randomized trial. The major variables included in the analyses were age, sex, education, household income, duration of low back pain episode for more than 2 weeks, presence of sciatica, workers’ compensation status, and the Work Adaptation, Partnership, Growth, Affection, and Resolve Survey (a measure of job satisfaction).¹⁶ In each of the studies, outcome measures from repeated interviews included data on functional status over time and pain levels. Data on satisfaction with care, return to work, and time to functional and complete recovery were obtained either at 8 weeks or when the patients were better. The main outcome measures were the Roland-Morris adaptation of the Sickness Impact Profile (a 23-item scale with high scores indicating significant dysfunction), patients’ report of being all better or functionally better, and the date they were able to return to performing their usual daily activities.^10,14 Patient satisfaction measures were based on the scale developed by Cherkin and colleagues.⁸ The patient was the unit of analysis.

Pearson’s chi-square was used when comparing the 3 patient groups by physician performance and patient satisfaction, adjusting for baseline differences. Linear modeling was used to examine the relationship of manual therapy to functional status (Roland-Morris score). Cox proportional hazard modeling was undertaken to identify survival curves of time to functional recovery. In all analyses, standard errors were corrected for any intraclass correlation due to nonindependence of patients seeing the same physician.¹⁷

Results

The 13 physicians cared for 120 patients in the observational study and 191 patients in the randomized trial [Figure 1]. In each of the studies very similar numbers of patients were seen by each physician. Within the 2 arms of the randomized trial of manual therapy, baseline characteristics were essentially the same [Table 1].

There were some differences in baseline characteristics between patients in the cohort study and the randomized trial. More patients in the randomized trial (41.4% vs 25%, P=.01) had significantly higher severe baseline dysfunction (Roland-Morris score=16-23) than in the cohort study. The mean baseline Roland Morris score was 10.0 for the cohort study patients compared with 12.5 for the manual therapy study patients (P=.03). There were more patients on workers’ compensation in the cohort study (35%) than in the manual therapy study (16.3%, P=.002), and fewer had been employed in the previous 3 months (80.8% vs 90.0%, P=.02).

Patients in both arms of the randomized manual therapy trial were significantly more satisfied than their counterparts in the earlier cohort study in terms of how their physician gave care in the clinical encounter and whether they received effective advice [Table 2]. Patients participating in the manual therapy trial were also more satisfied with their pain relief, their physicians’ overall treatment of back pain, and their ability to perform activities of daily living. Specific items of clinical performance where differences were noted included: the physician took a detailed history; gave useful advice on pain, preventive measures, sleeping, and sitting strategies; and provided back exercises. There were no differences in patient ratings of the physician’s ability to listen effectively, perform a careful physical examination, and explain the cause of their back pain. There were no differences in general health status between the cohort and manual therapy study patients.

When adjusted for baseline function, the presence of sciatica, duration of pain, employment status, workers’ compensation, and income of more than $20,000, mean functional outcomes measured by Roland-Morris scores at 2 weeks were 8.2 for the patients in the cohort study and 6.7 in the manual therapy trial (P=.03); at 4 weeks mean scores were 7.2 for the cohort and 5.2 for patients in the manual therapy trial (P=.02), and at 8 weeks scores were 6.7 and 3.6, respectively (P=.002). These were clinically significant differences showing that all patients in the clinical trial had lower functional disability levels during an 8-week period than patients of the same physicians in the cohort study.

After controlling for baseline Roland-Morris score, duration of low back pain, sciatica, employment status, workers’ compensation, and income more than $20,000, time to functional recovery reported by the patient (using Cox proportional hazard modeling) between the 3 groups of patients was as follows: (1) manual therapy + enhanced care versus cohort: hazard ratio (HR)=1.16; 95% confidence interval (CI), 0.85-1.58; (2) enhanced care alone versus cohort: HR=1.13; 95% CI, 0.82-1.54; and (3) manual therapy + enhanced care versus enhanced care alone: HR=1.03; 95% CI, 0.75-1.40. None of these HRs were significant [Figure 2].

Discussion

Data from patients of 13 physicians involved in an observational study of back care, followed by a randomized trial of the effect of additional clinical skills developed by hands-on training, provide an unusual opportunity to study patient outcomes and physician performance over time. Similar eligibility and exclusion criteria, data collection methods, and outcome measures were used in both studies, allowing us to directly compare the variables of interest.

After controlling for confounding factors and physician clustering effect, patients in the clinical trial of manual therapy had significantly more baseline dysfunction at the index visit but still recovered more rapidly by self-report. After workshop training for the physicians, the proportion of patients who reported effective evaluation and management of their back problem increased substantially.

There were no differences in the 2 studies in the proportions of patients reporting on how effectively their physician listened to them, explained causation, and discussed occupational issues. These latter activities were not specifically addressed in the training workshop, which concentrated on clinical evaluation, manual techniques, and issues of physical rehabilitation. One would expect that a general placebo effect on patients of the training would increase all parameters of their perceptions of care, so the workshop may have produced specific learning effects on the clinicians. Despite a trend favoring the group receiving care from the “trained” physicians, there were no significant differences in how patients perceived the quality of the physician’s physical examination of their back—an item that was particularly emphasized in the workshops. This aspect of physician performance was already highly rated in the cohort group and may have been less likely to show improvement, given the need to know what constitutes a superior examination technique.

The improved reported performances of physicians and patient outcomes were noted in both arms of the manual therapy trial, compared with those of patients in the earlier cohort study, though there was no difference in time to full functional recovery between the 2 studies. The inconsistency between outcomes (Roland-Morris scores and time to functional recovery) is probably explainable by the fact that they measure different patient perceptions of back problems—specific versus global recovery. This inconsistency of measures has been noted in other studies of low back pain interventions.¹⁸

The improved outcomes of patients in the randomized trial compared with those in the cohort may be because of specific elements of the study applicable to all patients or may have been due to unmeasured baseline differences. The patients in the randomized trial were more impaired at baseline, which would tend toward worse rather than better outcomes if severity was not completely controlled for. There are several possible explanations for these findings: (1) workshop training did improve physician knowledge and skills; (2) involvement of patients in a clinical trial in which an intervention (enhanced care) was given in both arms of the study (one also receiving manual therapy) could heighten the overall positive effect; (3) the clinical trial involved more visits (average=3.6) than with patients in the first study (1.3)—this could add significantly to patient satisfaction and perceptions of good care; and (4) the recruited physicians were a special group of interested and motivated individuals who by their nature would produce better outcomes in a clinical trial.

Limitations

There are limitations to our findings and conclusions. There were differences in exclusion criteria that might have reduced the number of unhealthy people recruited into the manual therapy trial compared with the cohort study. This could have led to better outcomes, though we doubt that these differences made much impact given the average age of the patients (40 years).

Although we adjusted for baseline differences (income, workers’ compensation, and employment status), we are not sure why these differences occurred. One possibility is that the rapid population and commercial growth and high employment rates that occurred in the state of North Carolina in the time between the 2 studies improved the economic characteristics of patients presenting to the physicians over time. It is also possible that patients with higher incomes and fewer employment difficulties would be more likely to rate physician communication and management more highly and improve more rapidly.

The global effect on clinician knowledge, skills, and performance of a 3-year span of evolving clinical practice and involvement in low back pain studies (other than participating in a training workshop) cannot be quantified. For example, improved performance and outcomes might have been related to the publication of the AHCPR back pain guidelines in 1994, approximately 6 months before the start of the manual therapy study.¹⁶ However, at the low back pain workshop (where only the AHCPR “red flags” were presented) the participants seemed to be only minimally aware of these guidelines.

If the improved outcomes noted in this study were mainly because of the passage of time rather than workshop training, this provides an interesting insight into how practice changes for the better.

Patient satisfaction with care has been shown to correlate with outcomes.^19,20 Deyo and Diehl suggested that dissatisfaction with care for low back pain was related to failure to obtain an adequate explanation from the physician, while Cherkin and colleagues proposed that lack of confidence in management and negative attitudes of clinicians might be key issues to be addressed in achieving better outcomes.^8-10,21,22 However, didactic training to remedy these problems did not appear to be very effective in improving satisfaction. Following up on these suggestions, Smucker and coworkers,¹² using the large North Carolina cohort study, showed that clinician self-confidence (allopathic and chiropractic physicians) did not predict patient outcomes but commented that communication, time spent with the patient, and manual evaluation and treatment skills might be important variables affecting outcome.¹²

The margin of differences in outcomes shown in our preintervention and postintervention analysis leads us to suggest that allopathic physicians using a brief systematic evaluation and hands-on regional physical examination, sound advice on pain management and prevention, and an increasingly active exercise program can modestly improve early patient functioning and satisfaction in acute low back pain. Whether training in limited manual therapy adds to this benefit is unclear and must be taken into account in relation to the current expansion of CME in manipulative skills for allopathic physicians. The costs and benefits of providing this training—with the possibility of needing one extra office visit or more to fully implement enhanced care—would need to be assessed.²³