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

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

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

Study Overview

• Status: Unknown
• Conditions: Dyspareunia
• Intervention / Treatment: Procedure: Pelvic Rehabilitation; Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Division of Urogynecology, University of Cincinnati Medical Center
      • Contact: Dani Zoorob, MD; Phone Number: 513-562-9080; Email: zoorobdg@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.; Other Names: Triamcinolone Acetonide-Total dose of 40mg, Volume 2 ml; Bupivacaine Hydrochloride-Strength 0.5%, Volume 18ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Patty Brisben Foundation For Women's Sexual Health
• Investigators: Principal Investigator: Mary South, MD, University of Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2014
• Study Completion (ANTICIPATED): June 1, 2014

Study Registration Dates

• First Submitted: December 21, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (ESTIMATE): December 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Trigger Point Injections; Dyspareunia; Pelvic Floor Myalgia; Pelvic Rehabilitation
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Bupivacaine
• Other Study ID Numbers: UC IRB Study #: 2013-0677; Patty Brisben Foundation (OTHER_GRANT: Patty Brisben Foundation)