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

NCT02022722 | Unknown Phase 4

• 2 other identifiers: UC IRB Study #: 2013-0677Patty Brisben Foundation
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyspareunia

Keywords

Pelvic Floor Myalgia; Trigger Point Injections; Pelvic Rehabilitation; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in sexual function between visit 1 and visit 10

  Baseline, Week 10

Study Arms (2)

Pelvic Rehabilitation

ACTIVE COMPARATOR

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

Procedure: Pelvic Rehabilitation

Trigger Point Injections

ACTIVE COMPARATOR

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

Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

Interventions

Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride DRUG

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

Also known as: Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml, Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml

Trigger Point Injections

Pelvic Rehabilitation PROCEDURE

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

Also known as: Pelvic floor massage

Pelvic Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pelvic pain
• pelvic floor myalgia
• dyspareunia
• female
• age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead
• Patty Brisben Foundation For Women's Sexual Health: collaborator

Study Sites (1)

Division of Urogynecology, University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 8598948 BACKGROUND

• 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.

  PMID: 19222415 RESULT

• 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.

  PMID: 17195176 RESULT

• 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.

  PMID: 15089868 RESULT

MeSH Terms

Conditions

Dyspareunia; Vaginismus

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mary South, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dani Zoorob, MD

CONTACT

5135629080; zoorobdg@ucmail.uc.edu

Mary South, MD

CONTACT

5135629080; southmm@ucmai.uc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director of Female Pelvic Medicine & Reconstructive Surgery

Study Record Dates

• First Submitted: December 21, 2013
• First Posted: December 30, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

US (1)