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

Sponsor

University of Cincinnati (Other)

Overall Status

Unknown status

CT.gov ID

NCT02022722

Collaborator

Patty Brisben Foundation For Women's Sexual Health (Other)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dyspareunia	Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride Procedure: Pelvic Rehabilitation	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pelvic Rehabilitation Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks	Procedure: Pelvic Rehabilitation Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy Other Names: Pelvic floor massage
Active Comparator: Trigger Point Injections Trigger point injections will be administered on weekly basis for a total of 6 weeks	Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature. Other Names: Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml

Arm

Intervention/Treatment

Active Comparator: Pelvic Rehabilitation

Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks

Procedure: Pelvic Rehabilitation

Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy

Other Names:

Pelvic floor massage

Active Comparator: Trigger Point Injections

Trigger point injections will be administered on weekly basis for a total of 6 weeks

Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.

Other Names:

Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml

Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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