Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
Overview
- Phase
- Phase 4
- Intervention
- Pelvic Rehabilitation
- Conditions
- Dyspareunia
- Sponsor
- University of Cincinnati
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
- Last Updated
- 12 years ago
Overview
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.
Investigators
Mary South
MD, Director of Female Pelvic Medicine & Reconstructive Surgery
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •pelvic pain
- •pelvic floor myalgia
- •dyspareunia
- •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
Arms & Interventions
Pelvic Rehabilitation
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
Intervention: Pelvic Rehabilitation
Trigger Point Injections
Trigger point injections will be administered on weekly basis for a total of 6 weeks
Intervention: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in sexual function between visit 1 and visit 10(Baseline, Week 10)