Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Pelvic Pain Clinical Trial

Official title:

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885791
• Other study ID #: 201901209
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2021
• Source: Washington University School of Medicine
• Contact: Jerry Lowder, MD
• Phone: 3147471402
• Email: lowderj[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes
• Pelvic Floor Myofascial Pain
• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Outpatient Health/Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-15 minutes (Pre- to post-treatment)
Secondary	Pelvic Floor Distress Inventory-20	Short form of the validated questionnaire to assess presence and degree of bother of common pelvic floor symptoms	2 weeks
Secondary	Pelvic Floor Impact Questionnaire-7	Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities	2 weeks
Secondary	Prolapse and Incontinence Sexual Questionnaire	Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity	2 weeks
Secondary	Urogenital Distress Inventory	Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms	2 weeks
Secondary	Lower Urinary Tract Symptoms (LUTS) Tool	Validated questionnaire to assess lower urinary tract symptoms	2 weeks