NCT03885791

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pelvic Floor Myofascial Pain
• Pelvic Pain
• Myofascial Pain

Interventions

Type	Name	Description
DEVICE	vaginal cryotherapy	Both groups will be given the same instructions for use, which will include intravaginal placement of one tube for 10 minutes while resting in a supine position. A lubricant may be used for comfort with insertion. Patients will perform their first intervention in the office with a repeat examination within 10 minutes of completing therapy. Patients participating in Specific Aims #2 will perform the intervention once daily at home. Patients will be asked to complete a short diary for each session, which will include the time of day, duration of application, pain score prior to and after application, and presence of any pelvic floor disorder symptoms prior to and after application.

Timeline

• Start date: 2019-03-22
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2019-03-22
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States