Endometriosis pain stemming from pelvic spasms improved with botulinum toxin

 

LOS ANGELES – Women treated surgically and with hormones for endometriosis may continue to experience pain, say investigators, and that pain frequently extends beyond the pelvis.

At the annual meeting of the American Academy of Neurology, Barbara Karp, MD, of the National Institute of Neurological Disorders and Stroke, presented results from an ongoing randomized trial of women with endometriosis receiving botulinum toxin to treat endometriosis-related chronic pelvic pain and pelvic spasm.

designer491/Thinkstock

“When we saw the women with endometriosis we realized there was more going on, and that they were very broadly sensitized to pain,” Dr. Karp said in an interview. “So we started looking at that systematically.”

All 28 women currently enrolled in the trial (median age, 29 years) were evaluated by a gynecologist to confirm pelvic muscle spasm as their primary source of pain. Each also underwent a neuromuscular examination to identify pain points beyond the pelvis.

All subjects had myofascial dysfunction. Most reported headaches and half reported orofacial pain, while 13 subjects reported myofascial trigger points in all the 26 spots assessed, which included head and facial muscles, shoulder and back muscles, and muscles in the buttocks, abdomen, and upper legs.

Dr. Karp said her group hypothesized that for patients with endometriosis, the widespread pain seen in the study “probably has some origin in sensitization initiated by pain associated with the endometriosis lesions, and that gives us a mechanism to think about peripheral and central sensitization.” But she noted that such sensitization can be easily missed in the clinic.

“One of the things that’s really underappreciated is how much women with chronic pelvic pain have pain elsewhere. So the neurologist or pain specialist may say, ‘that’s not my body territory, there’s something going on with your pelvis.’ And the gynecologist may be focused on the endometriosis and the endometriosis lesions. So you have these women with really widespread pain problems whose care is being fractionated.”

 

In another aspect of the study she also presented at the meeting, Dr. Karp, a neurologist who has studied the therapeutic use of neurotoxins such as botulinum for 30 years, showed results from an open-label extension of a randomized trial of botulinum toxin injections to treat pelvic spasm in the same cohort of women with confirmed endometriosis and confirmed pelvic muscle spasm.

The researchers looked at results for 13 women who opted for an open-label injection of 100 U of onabotulinumtoxinA (Botox) to treat pelvic spasm, after having received a double-masked, randomized injection of either the same dose of Botox or placebo. The open-label injection was at a time of the participant’s choosing, between 1 month to 1 year after the randomized injection. Pain levels and disability were high for the group as a whole.

A month after the open-label injection, spasm was reduced or absent in all subjects (P = .0005), with 11 of 13 rating pain as absent or mild (P = .0001), Dr. Karp and her colleagues reported. Between 5 and 11 months post injection, five women requested a repeat of the treatment.

Besides the data on pain and disability collected as part of the trial, Dr. Karp and her colleagues are also looking at biomarkers for pain and inflammation, and changes in medication and hormone use. They are preparing a separate literature review on injection techniques and dosages of toxin to the pelvic floor muscles.

 

“It’s an area of the body neurologists don’t feel comfortable injecting, and I don’t necessarily feel comfortable doing it myself,” Dr. Karp said.

The researchers had to develop their own procedure because at the time they started the research there was almost nothing in the literature on how to inject botulinum toxin for pelvic pain in women. “People in different specialties have been doing it [to relieve pelvic pain] and it’s really widespread, but they’re doing it all different ways,” Dr. Karp said. “We’re hoping to find a best approach.”

Dr. Karp and her colleagues’ research is supported by the NINDS and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. OnabotulinumtoxinA for the clinical trial is supplied by Allergan. Dr. Karp has received research support from Allergan and Merz.

SOURCE: Karp B et al. AAN 2018, Abstract P2.096; Karp B et al. AAN 2018, Abstract P2.098.

 

LOS ANGELES – Women treated surgically and with hormones for endometriosis may continue to experience pain, say investigators, and that pain frequently extends beyond the pelvis.

At the annual meeting of the American Academy of Neurology, Barbara Karp, MD, of the National Institute of Neurological Disorders and Stroke, presented results from an ongoing randomized trial of women with endometriosis receiving botulinum toxin to treat endometriosis-related chronic pelvic pain and pelvic spasm.

designer491/Thinkstock

“When we saw the women with endometriosis we realized there was more going on, and that they were very broadly sensitized to pain,” Dr. Karp said in an interview. “So we started looking at that systematically.”

All 28 women currently enrolled in the trial (median age, 29 years) were evaluated by a gynecologist to confirm pelvic muscle spasm as their primary source of pain. Each also underwent a neuromuscular examination to identify pain points beyond the pelvis.

All subjects had myofascial dysfunction. Most reported headaches and half reported orofacial pain, while 13 subjects reported myofascial trigger points in all the 26 spots assessed, which included head and facial muscles, shoulder and back muscles, and muscles in the buttocks, abdomen, and upper legs.

Dr. Karp said her group hypothesized that for patients with endometriosis, the widespread pain seen in the study “probably has some origin in sensitization initiated by pain associated with the endometriosis lesions, and that gives us a mechanism to think about peripheral and central sensitization.” But she noted that such sensitization can be easily missed in the clinic.

“One of the things that’s really underappreciated is how much women with chronic pelvic pain have pain elsewhere. So the neurologist or pain specialist may say, ‘that’s not my body territory, there’s something going on with your pelvis.’ And the gynecologist may be focused on the endometriosis and the endometriosis lesions. So you have these women with really widespread pain problems whose care is being fractionated.”

 

In another aspect of the study she also presented at the meeting, Dr. Karp, a neurologist who has studied the therapeutic use of neurotoxins such as botulinum for 30 years, showed results from an open-label extension of a randomized trial of botulinum toxin injections to treat pelvic spasm in the same cohort of women with confirmed endometriosis and confirmed pelvic muscle spasm.

The researchers looked at results for 13 women who opted for an open-label injection of 100 U of onabotulinumtoxinA (Botox) to treat pelvic spasm, after having received a double-masked, randomized injection of either the same dose of Botox or placebo. The open-label injection was at a time of the participant’s choosing, between 1 month to 1 year after the randomized injection. Pain levels and disability were high for the group as a whole.

A month after the open-label injection, spasm was reduced or absent in all subjects (P = .0005), with 11 of 13 rating pain as absent or mild (P = .0001), Dr. Karp and her colleagues reported. Between 5 and 11 months post injection, five women requested a repeat of the treatment.

Besides the data on pain and disability collected as part of the trial, Dr. Karp and her colleagues are also looking at biomarkers for pain and inflammation, and changes in medication and hormone use. They are preparing a separate literature review on injection techniques and dosages of toxin to the pelvic floor muscles.

 

“It’s an area of the body neurologists don’t feel comfortable injecting, and I don’t necessarily feel comfortable doing it myself,” Dr. Karp said.

The researchers had to develop their own procedure because at the time they started the research there was almost nothing in the literature on how to inject botulinum toxin for pelvic pain in women. “People in different specialties have been doing it [to relieve pelvic pain] and it’s really widespread, but they’re doing it all different ways,” Dr. Karp said. “We’re hoping to find a best approach.”

Dr. Karp and her colleagues’ research is supported by the NINDS and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. OnabotulinumtoxinA for the clinical trial is supplied by Allergan. Dr. Karp has received research support from Allergan and Merz.

SOURCE: Karp B et al. AAN 2018, Abstract P2.096; Karp B et al. AAN 2018, Abstract P2.098.

 

LOS ANGELES – Women treated surgically and with hormones for endometriosis may continue to experience pain, say investigators, and that pain frequently extends beyond the pelvis.

At the annual meeting of the American Academy of Neurology, Barbara Karp, MD, of the National Institute of Neurological Disorders and Stroke, presented results from an ongoing randomized trial of women with endometriosis receiving botulinum toxin to treat endometriosis-related chronic pelvic pain and pelvic spasm.

designer491/Thinkstock

“When we saw the women with endometriosis we realized there was more going on, and that they were very broadly sensitized to pain,” Dr. Karp said in an interview. “So we started looking at that systematically.”

All 28 women currently enrolled in the trial (median age, 29 years) were evaluated by a gynecologist to confirm pelvic muscle spasm as their primary source of pain. Each also underwent a neuromuscular examination to identify pain points beyond the pelvis.

All subjects had myofascial dysfunction. Most reported headaches and half reported orofacial pain, while 13 subjects reported myofascial trigger points in all the 26 spots assessed, which included head and facial muscles, shoulder and back muscles, and muscles in the buttocks, abdomen, and upper legs.

Dr. Karp said her group hypothesized that for patients with endometriosis, the widespread pain seen in the study “probably has some origin in sensitization initiated by pain associated with the endometriosis lesions, and that gives us a mechanism to think about peripheral and central sensitization.” But she noted that such sensitization can be easily missed in the clinic.

“One of the things that’s really underappreciated is how much women with chronic pelvic pain have pain elsewhere. So the neurologist or pain specialist may say, ‘that’s not my body territory, there’s something going on with your pelvis.’ And the gynecologist may be focused on the endometriosis and the endometriosis lesions. So you have these women with really widespread pain problems whose care is being fractionated.”

 

In another aspect of the study she also presented at the meeting, Dr. Karp, a neurologist who has studied the therapeutic use of neurotoxins such as botulinum for 30 years, showed results from an open-label extension of a randomized trial of botulinum toxin injections to treat pelvic spasm in the same cohort of women with confirmed endometriosis and confirmed pelvic muscle spasm.

The researchers looked at results for 13 women who opted for an open-label injection of 100 U of onabotulinumtoxinA (Botox) to treat pelvic spasm, after having received a double-masked, randomized injection of either the same dose of Botox or placebo. The open-label injection was at a time of the participant’s choosing, between 1 month to 1 year after the randomized injection. Pain levels and disability were high for the group as a whole.

A month after the open-label injection, spasm was reduced or absent in all subjects (P = .0005), with 11 of 13 rating pain as absent or mild (P = .0001), Dr. Karp and her colleagues reported. Between 5 and 11 months post injection, five women requested a repeat of the treatment.

Besides the data on pain and disability collected as part of the trial, Dr. Karp and her colleagues are also looking at biomarkers for pain and inflammation, and changes in medication and hormone use. They are preparing a separate literature review on injection techniques and dosages of toxin to the pelvic floor muscles.

 

“It’s an area of the body neurologists don’t feel comfortable injecting, and I don’t necessarily feel comfortable doing it myself,” Dr. Karp said.

The researchers had to develop their own procedure because at the time they started the research there was almost nothing in the literature on how to inject botulinum toxin for pelvic pain in women. “People in different specialties have been doing it [to relieve pelvic pain] and it’s really widespread, but they’re doing it all different ways,” Dr. Karp said. “We’re hoping to find a best approach.”

Dr. Karp and her colleagues’ research is supported by the NINDS and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. OnabotulinumtoxinA for the clinical trial is supplied by Allergan. Dr. Karp has received research support from Allergan and Merz.

SOURCE: Karp B et al. AAN 2018, Abstract P2.096; Karp B et al. AAN 2018, Abstract P2.098.