Clinical Trial: Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections

Brief Summary: The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.

Detailed Summary: Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
Sponsor: University of Cincinnati

Current Primary Outcome: Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale [ Time Frame: Baseline, Week 10 ]

Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in sexual function between visit 1 and visit 10 [ Time Frame: Baseline, Week 10 ]

Change in sexual function based on the female sexual function index (19 questions, one final score, maximum score of 36) where the patients fill a questionnaire prior to the first treatment session and after the completion of the treatment at week 10.


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: December 21, 2013
Date Started: August 2013
Date Completion: June 2014
Last Updated: December 27, 2013
Last Verified: December 2013