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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02022722
Recruitment Status : Unknown
Verified December 2013 by Mary South, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Patty Brisben Foundation For Women's Sexual Health
Information provided by (Responsible Party):
Mary South, University of Cincinnati

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

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

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  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment Of Pain Subsidence And Sexual Function Amelioration Using Either Pelvic Rehabilitation Or Trigger Point Injections
Study Start Date : August 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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 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

Primary Outcome Measures :
  1. Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale [ Time Frame: Baseline, Week 10 ]
    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 :
  1. Change in sexual function between visit 1 and visit 10 [ Time Frame: Baseline, Week 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02022722

Contact: Dani Zoorob, MD 5135629080
Contact: Mary South, MD 5135629080

United States, Ohio
Division of Urogynecology, University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dani Zoorob, MD    513-562-9080   
Sponsors and Collaborators
University of Cincinnati
Patty Brisben Foundation For Women's Sexual Health
Principal Investigator: Mary South, MD University of Cincinnati

Publications of Results:
Other Publications:
Responsible Party: Mary South, MD, Director of Female Pelvic Medicine & Reconstructive Surgery, University of Cincinnati Identifier: NCT02022722     History of Changes
Other Study ID Numbers: UC IRB Study #: 2013-0677
Patty Brisben Foundation ( Other Grant/Funding Number: Patty Brisben Foundation )
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Mary South, University of Cincinnati:
Pelvic Floor Myalgia
Trigger Point Injections
Pelvic Rehabilitation

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