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

Dyspareunia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02022722
• Other study ID #: UC IRB Study #: 2013-0677
• Secondary ID: Patty Brisben Fo
• Status: Unknown status
• Phase: Phase 4
• First received: December 21, 2013
• Last updated: December 27, 2013
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: University of Cincinnati
• Contact: Dani Zoorob, MD
• Phone: 5135629080
• Email: zoorobdg[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 36
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia

Intervention

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.

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

Locations

Country	Name	City	State
United States	Division of Urogynecology, University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Patty Brisben Foundation For Women's Sexual Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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