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

Phase 4

• Conditions: Dyspareunia
• Interventions: Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride; Procedure: Pelvic Rehabilitation

• Registration Number: NCT02022722
• Lead Sponsor: University of Cincinnati

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-21
• Study First Submitted QC: 2013-12-27
• Last Update Submitted: 2013-12-27
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30
• Primary Completion: 2014-04
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• pelvic pain
• pelvic floor myalgia
• dyspareunia
• female
• age > 18 years

Exclusion Criteria

• interstitial cystitis
• vaginal lesions / ulcerations
• prior trigger point injections in the past 6 months
• prior pelvic rehabilitation in the past 6 months
• laparoscopically documented endometriosis / pelvic adhesions or adhesive disease
• documented pelvic inflammatory disease identified within the past 6 months
• documented sexually transmitted disease within the past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trigger Point Injections	Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride	Trigger point injections will be administered on weekly basis for a total of 6 weeks
Pelvic Rehabilitation	Pelvic Rehabilitation	Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks

Primary Outcome Measures

Name	Time	Method
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change in sexual function between visit 1 and visit 10	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.

Trial Locations

Locations (1)

Division of Urogynecology, University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States