Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
NCT ID: NCT02022722
Last Updated: 2013-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
36 participants
INTERVENTIONAL
2013-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pelvic Rehabilitation
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
Pelvic Rehabilitation
Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
Trigger Point Injections
Trigger point injections will be administered on weekly basis for a total of 6 weeks
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.
Interventions
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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.
Pelvic Rehabilitation
Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pelvic floor myalgia
* dyspareunia
* female
* age \> 18 years
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Patty Brisben Foundation For Women's Sexual Health
OTHER
University of Cincinnati
OTHER
Responsible Party
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Mary South
MD, Director of Female Pelvic Medicine & Reconstructive Surgery
Principal Investigators
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Mary South, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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Division of Urogynecology, University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Dani Zoorob, MD
Role: primary
References
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Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996 Mar;87(3):321-7. doi: 10.1016/0029-7844(95)00458-0.
Rao SS, Paulson J, Mata M, Zimmerman B. Clinical trial: effects of botulinum toxin on Levator ani syndrome--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2009 May 1;29(9):985-91. doi: 10.1111/j.1365-2036.2009.03964.x. Epub 2009 Feb 13.
Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62. doi: 10.1002/nau.20393.
Jarvis SK, Abbott JA, Lenart MB, Steensma A, Vancaillie TG. Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles. Aust N Z J Obstet Gynaecol. 2004 Feb;44(1):46-50. doi: 10.1111/j.1479-828X.2004.00163.x.
Other Identifiers
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Patty Brisben Foundation
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UC IRB Study #: 2013-0677
Identifier Type: -
Identifier Source: org_study_id