Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Not Applicable

• Conditions: Pelvic Pain; Pelvic Floor Myofascial Pain; Myofascial Pain

• Registration Number: NCT03885791
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is a placebo-controlled, randomized controlled trial to investigate the role of vaginal cryotherapy on pelvic floor myofascial pain in women. This study involves randomizing patients who are found to have pelvic floor myofascial pain on examination into one of two treatment groups: transvaginal cryotherapy or transvaginal application of a room-temperature tube. Patients will be followed up at two different time points in order to assess response to treatment. Follow-up times include immediately after application (Specific Aim #1) and two weeks following use of the intervention alone (Specific Aim #2). Patients will receive verbal and written instructions on using the intravaginal tubes by the research assistant who will not be blinded to treatment allocation. Patients will not be blinded to their treatment assignment but will not be given information on the alternative treatment. Patients will be referred to pelvic floor PT, which is considered the standard of care for treatment of pelvic floor myofascial pain at this time. As it typically takes 2-3 weeks to get in to see one of the pelvic floor PT providers at Wash U, follow up for this study will be completed prior to their attendance at pelvic floor PT. Patients will complete validated questionnaires assessing their pain, other pelvic floor symptoms, and acceptance of the intervention as a treatment option at the follow up time points.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-19
• Study Start: 2019-03-22
• Study First Posted: 2019-03-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-05
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

• Adult (>18yo)
• Women
• Patients found to have pelvic floor myofascial pain of at least 4/10 in severity at any of the four sites (right obturator internus, right levator ani, left levator ani, left obturator internus)

Exclusion Criteria

• Age <18
• Non-English speaking
• Current diagnosis of dementia
• Limited physical mobility that would prevent full participation in pelvic floor PT.
• Prior use of vaginal cryotherapy
• Chief complaint or known history of pelvic pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in myofascial pain score	10-15 minutes (Pre- to post-treatment)	Primary outcome is change in pelvic floor myofascial pain scores at each site (bilateral OI and LA) as measured on a 0-10 visual pain rating scale where 0 indicates no pain on palpation and 10 indicates 'worst pain imaginable' on palpation.

Secondary Outcome Measures

Name	Time	Method
Pelvic Floor Impact Questionnaire-7	2 weeks	Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities
Urogenital Distress Inventory	2 weeks	Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms
Lower Urinary Tract Symptoms (LUTS) Tool	2 weeks	Validated questionnaire to assess lower urinary tract symptoms
Pelvic Floor Distress Inventory-20	2 weeks	Short form of the validated questionnaire to assess presence and degree of bother of common pelvic floor symptoms
Prolapse and Incontinence Sexual Questionnaire	2 weeks	Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity

Trial Locations

Locations (1)

Center for Outpatient Health/Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States