Clinical trial NCT03885791: Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Official title: Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Myofascial Pain
Pelvic Pain
Myofascial Pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in myofascial pain score
timeFrame: 10-15 minutes (Pre- to post-treatment)
Secondary outcomes:
measure: Pelvic Floor Distress Inventory-20
timeFrame: 2 weeks
measure: Pelvic Floor Impact Questionnaire-7
timeFrame: 2 weeks
measure: Prolapse and Incontinence Sexual Questionnaire
timeFrame: 2 weeks
measure: Urogenital Distress Inventory
timeFrame: 2 weeks
measure: Lower Urinary Tract Symptoms (LUTS) Tool
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Center for Outpatient Health/Washington University in St. Louis
state: Missouri
Study officials:
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