Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
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.
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