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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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: To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy.

Hypothesis We hypothesize that women in the Botox treatment arm, compared with those in the saline arm, will have a greater decrease in patient-reported pain on palpation of their most painful levator ani muscle group at two weeks after the injection.

To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and two weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and two-week pain measurements for the most painful muscle group.

We hypothesize that with the addition of physical therapy, women in the Botox treatment arm, compared with those in the saline arm, have a greater decrease in patient-reported pain on palpation of their most painful levator ani muscle group at 12 weeks after the injection.

To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and 12 weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and 12-week pain measurements for the most painful muscle group.

Intervention:

All patien
Sponsor: Boston Urogynecology Associates

Current Primary Outcome: To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline. [ Time Frame: 2 weeks after pelvic floor injection ]

To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and two weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and two-week pain measurements for the most painful muscle group.


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy. [ Time Frame: 12 weeks following pelvic floor injection ]

To test this we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and 12 weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and 12-week pain measurements for the most painful muscle group.


Original Secondary Outcome: Same as current

Information By: Boston Urogynecology Associates

Dates:
Date Received: July 18, 2013
Date Started: July 2013
Date Completion: June 2019
Last Updated: February 14, 2017
Last Verified: February 2017