Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Urogynecology Associates
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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