Clinical trial NCT02022722: Trigger Point Injections and Pelvic Rehabilitation for the Treatment of Pelvic Floor Myalgia and Sexual Pain
Official title: Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyspareunia
Keywords: Pelvic Floor Myalgia
Trigger Point Injections
Pelvic Rehabilitation
Dyspareunia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Patty Brisben Foundation For Women's Sexual Health
First posted: 2013-12-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Change in sexual function between visit 1 and visit 10
timeFrame: Baseline, Week 10
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Division of Urogynecology, University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mary South, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.