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

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

Detailed Description
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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.

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

Conditions
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Dyspareunia

Intervention / Treatment
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* Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
* Procedure: Pelvic Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic Rehabilitation<br>Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks | Procedure: Pelvic Rehabilitation<br>* Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy<br>* Other names: Pelvic floor massage;|
| Active Comparator: Trigger Point Injections<br>Trigger point injections will be administered on weekly basis for a total of 6 weeks | Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride<br>* The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.<br>* Other names: Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale | 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. | Baseline, Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual function between visit 1 and visit 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. | Baseline, Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia