Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
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|ClinicalTrials.gov Identifier: NCT02022722|
Recruitment Status : Unknown
Verified December 2013 by Mary South, University of Cincinnati.
Recruitment status was: Recruiting
First Posted : December 30, 2013
Last Update Posted : December 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Dyspareunia||Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride Procedure: Pelvic Rehabilitation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
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 Name: 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022722
|Contact: Dani Zoorob, MDemail@example.com|
|Contact: Mary South, MDfirstname.lastname@example.org|
|United States, Ohio|
|Division of Urogynecology, University of Cincinnati Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Dani Zoorob, MD 513-562-9080 email@example.com|
|Principal Investigator:||Mary South, MD||University of Cincinnati|