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临床试验/NCT03885791
NCT03885791已完成不适用

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2019年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
change in myofascial pain score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult (>18yo)
  • 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)

排除标准

  • 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

研究组 & 干预措施

Vaginal cryotherapy - intervention

Experimental

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.

干预措施: vaginal cryotherapy (Device)

Vaginal cryotherapy - control

Placebo Comparator

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.

干预措施: vaginal cryotherapy (Device)

结局指标

主要结局

change in myofascial pain score

时间窗: 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.

次要结局

  • Pelvic Floor Impact Questionnaire-7(2 weeks)
  • Urogenital Distress Inventory(2 weeks)
  • Pelvic Floor Distress Inventory-20(2 weeks)
  • Lower Urinary Tract Symptoms (LUTS) Tool(2 weeks)
  • Prolapse and Incontinence Sexual Questionnaire(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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