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

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University of Cincinnati

Status and phase

Unknown
Phase 4

Conditions

Dyspareunia

Treatments

Procedure: Pelvic Rehabilitation
Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT02022722
Patty Brisben Foundation (Other Grant/Funding Number)
UC IRB Study #: 2013-0677

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Pelvic Rehabilitation
Active Comparator group
Description:
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
Treatment:
Procedure: Pelvic Rehabilitation
Trigger Point Injections
Active Comparator group
Description:
Trigger point injections will be administered on weekly basis for a total of 6 weeks
Treatment:
Drug: Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride

Trial contacts and locations

1

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Central trial contact

Mary South, MD; Dani Zoorob, MD

Data sourced from clinicaltrials.gov

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