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Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Primary Purpose

Pelvic Floor Myofascial Pain, Pelvic Pain, Myofascial Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vaginal cryotherapy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Myofascial Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Outpatient Health/Washington University in St. LouisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaginal cryotherapy - intervention

Vaginal cryotherapy - control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

change in myofascial pain score
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

Pelvic Floor Distress Inventory-20
Short form of the validated questionnaire to assess presence and degree of bother of common pelvic floor symptoms
Pelvic Floor Impact Questionnaire-7
Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities
Prolapse and Incontinence Sexual Questionnaire
Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity
Urogenital Distress Inventory
Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms
Lower Urinary Tract Symptoms (LUTS) Tool
Validated questionnaire to assess lower urinary tract symptoms

Full Information

First Posted
March 15, 2019
Last Updated
May 3, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03885791
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Myofascial Pain, Pelvic Pain, Myofascial Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaginal cryotherapy - intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Vaginal cryotherapy - control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
vaginal cryotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in myofascial pain score
Description
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.
Time Frame
10-15 minutes (Pre- to post-treatment)
Secondary Outcome Measure Information:
Title
Pelvic Floor Distress Inventory-20
Description
Short form of the validated questionnaire to assess presence and degree of bother of common pelvic floor symptoms
Time Frame
2 weeks
Title
Pelvic Floor Impact Questionnaire-7
Description
Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities
Time Frame
2 weeks
Title
Prolapse and Incontinence Sexual Questionnaire
Description
Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity
Time Frame
2 weeks
Title
Urogenital Distress Inventory
Description
Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms
Time Frame
2 weeks
Title
Lower Urinary Tract Symptoms (LUTS) Tool
Description
Validated questionnaire to assess lower urinary tract symptoms
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Lowder, MD
Phone
3147471402
Email
lowderj@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Haidy Morsy, MD
Phone
314-273-1905
Email
h.morsy@wustl.edu
Facility Information:
Facility Name
Center for Outpatient Health/Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Lowder, MD
Phone
314-747-1402
Email
lowderj@wustl.edu
First Name & Middle Initial & Last Name & Degree
Haidy Morsy, MD
Phone
314-273-1905
Email
h.morsy@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

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