Trial | NCT02022722  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    levobupivacaine triamcinolone ...

  • Study Participants

    36
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
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 Started
Aug 31
2013
Primary Completion
Apr 30
2014
Anticipated
Study Completion
Jun 30
2014
Anticipated
Last Update
Dec 30
2013
Estimate

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

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

Pelvic Rehabilitation Active Comparator

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

Trigger Point Injections Active Comparator

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

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
No Results Posted