Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Not Applicable

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vaginal cryotherapy - control	vaginal cryotherapy	The control group will be provided with an identical tube that is empty. An empty tube was chosen as the control because a tube with room-temperature liquid may still be perceived as cold. Patients will insert this tube into the vagina to a comfortable depth. A lubricant will be provided for comfort with tube insertion, if necessary. At the conclusion of the treatment, this tube will be washed thoroughly and given to the patient in a clean plastic baggie for use at home. They will be instructed to store these tubes in their home at room temperature.
Vaginal cryotherapy - intervention	vaginal cryotherapy	The intervention group will be provided with one vaginal cryotherapy tube, filled with a mixture of isopropyl alcohol (2ml) and water (8ml) that has been kept in the freezer. This mixture results in a "slushy" consistency and prevents the solution from freezing solid thus decreases the risk of discomfort or injury due to the temperature of the tube. Patients will insert this tube into the vagina to a comfortable depth. A lubricant will be provided for comfort with tube insertion, if necessary. At the conclusion of the treatment, this tube will be washed thoroughly and given to the patient in a clean plastic baggie for use at home. They will be instructed to store these tubes in their home freezer.

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
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
Lower Urinary Tract Symptoms (LUTS) Tool	2 weeks	Validated questionnaire to assess lower urinary tract 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

Locations (1): Center for Outpatient Health/Washington University in St. Louis
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Saint Louis, Missouri, United States