Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Myofascial Pelvic Pain
In brief
The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
Key facts
- Study ID
- NCT01905137
- Run by
- Boston Urogynecology Associates
- People needed
- 64
- Starts
- 2013-07-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2019-04-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than 18
- Diagnosis of myofascial pain by an attending urogynecologist
- Persistent pelvic pain present for ≥50% of days over the past 3 months at a level of 6 or greater on a 10-point visual analog scale
- On physical exam, a short, tight pelvic floor with pain on palpation of at least 6 on a 10-point visual analog scale in at least one muscle group (coccygeus, pyriformis, obturator internus, iliococcygeus, puborectalis, or pubococcygeus).
- Ability to read English, provide written, informed consent and be able and willing to go to pelvic floor physical therapy.
You may not qualify if…
- Pregnancy or breastfeeding
- Any of the following a pre-existing neurologic or neuromuscular condition that precludes them from Botox injections, such as myasthenia gravis, a bleeding disorder; or sensitivity or allergy to Botox
- Current use of aminoglycosides or any other medication that may potentiate the neuromuscular weakness that could be caused by concomitant use of Botox also will be ineligible
- History of treatment with Botox to the pelvic floor
- Presence of any masses or lesions on physical exam
- Pelvic organ prolapse greater than stage 2
- Plan for pelvic floor surgery or pelvic floor physical therapy treatment in the next three months
- Change in pain medication usage in the past 3 months
Where it is running
- Boston Urogynecology Associates — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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