Recruiting

Trigger Point Injections & Pelvic Rehabilitation

Sponsor:

University of Cincinnati

Code:

NCT02022722

Conditions

Dyspareunia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

Pelvic Rehabilitation

Study Details

Brief summary:

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

Conditions

Dyspareunia

Study ID

NCT02022722

Start date

Aug, 2013

Status verified date

Dec, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Apr, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pelvic Rehabilitation

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

active comparator: Trigger Point Injections

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

Interventions

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.

Pelvic Rehabilitation

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

Primary outcome measure

  • Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale [ Time Frame: Baseline, Week 10 ]

Central Contacts and Locations

Central contacts

Dani Zoorob, MD

5135629080zoorobdg@ucmail.uc.edu

Mary South, MD

5135629080southmm@ucmai.uc.edu

Locations

Division of Urogynecology, University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Dani Zoorob, MD

513-562-9080zoorobdg@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

Dec 30, 2013

Last verified

Dec, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2013-12-30.