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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Cincinnati
Sponsor:
Collaborator:
Patty Brisben Foundation For Women's Sexual Health
Information provided by (Responsible Party):
Mary South, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT02022722
First received: December 21, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Dyspareunia
Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
Procedure: Pelvic Rehabilitation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale [ Time Frame: Baseline, Week 10 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in sexual function between visit 1 and visit 10 [ Time Frame: Baseline, Week 10 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: August 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022722

Contacts
Contact: Dani Zoorob, MD 5135629080 zoorobdg@ucmail.uc.edu
Contact: Mary South, MD 5135629080 southmm@ucmai.uc.edu

Locations
United States, Ohio
Division of Urogynecology, University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dani Zoorob, MD    513-562-9080    zoorobdg@ucmail.uc.edu   
Sponsors and Collaborators
University of Cincinnati
Patty Brisben Foundation For Women's Sexual Health
Investigators
Principal Investigator: Mary South, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Mary South, MD, Director of Female Pelvic Medicine & Reconstructive Surgery, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02022722     History of Changes
Other Study ID Numbers: UC IRB Study #: 2013-0677, Patty Brisben Foundation
Study First Received: December 21, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Pelvic Floor Myalgia
Trigger Point Injections
Pelvic Rehabilitation
Dyspareunia

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Dyspareunia
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014