Status:
UNKNOWN
Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
Lead Sponsor:
Boston Urogynecology Associates
Collaborating Sponsors:
Allergan
Conditions:
Myofascial Pelvic Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
Objective: Primary objective: To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline. Secondary objective:...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01905137
Start Date
July 1 2013
End Date
June 1 2019
Last Update
April 12 2019
Active Locations (1)
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1
Boston Urogynecology Associates
Cambridge, Massachusetts, United States, 02138