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Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03885791
Collaborator
(none)
132
Enrollment
1
Location
2
Arms
33.3
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: vaginal cryotherapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Actual Study Start Date :
Mar 22, 2019
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vaginal cryotherapy - intervention

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.

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.
Placebo Comparator: Vaginal cryotherapy - control

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Pelvic Floor Impact Questionnaire-7 [2 weeks]

    Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities

  3. Prolapse and Incontinence Sexual Questionnaire [2 weeks]

    Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity

  4. Urogenital Distress Inventory [2 weeks]

    Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms

  5. Lower Urinary Tract Symptoms (LUTS) Tool [2 weeks]

    Validated questionnaire to assess lower urinary tract symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Outpatient Health/Washington University in St. Louis Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03885791
Other Study ID Numbers:
  • 201901209
First Posted:
Mar 22, 2019
Last Update Posted:
May 5, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myofascial Pain Syndromes
Pelvic Pain

Study Results

No Results Posted as of May 5, 2021