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临床试验/NCT05899088
NCT05899088尚未招募不适用

A Randomized Clinical Trial of Mindful Movement for Patients With Chronic Pelvic

The Miriam Hospital0 个研究点目标入组 60 人开始时间: 2023年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Change in Kinesiophobia and Pain Catastrophizing

研究概览

简要总结

Female chronic pelvic pain (CPP) is defined as the sensation of pain arising from the lower urinary tract, bowel, muscles, nerves, and gynecologic organs within the pelvis. It can also include menstrual pain and pain with intercourse, when these adversely affects a patient's well-being. Chronic pelvic pain is often associated with negative cognitive, behavioral, sexual and emotional consequences, which can include physical deconditioning, pain catastrophizing (magnifying the threat of pain), kinesiophobia (fear of movement), and depression. CPP has been estimated to affect between 5.7%-26.6% of women.Treatments for chronic pelvic pain are limited, and the use of centrally acting pain medications such as opioids is common. There is increasing awareness of the risks of these medications, including dependence, addiction, and over-dose related death. Therefore, it is critical to look for safe alternatives to manage chronic pelvic pain.

Exercise has been targeted as a treatment strategy for chronic pain conditions, improving both pain intensity and physical function. Studies have demonstrated that yoga, Zumba®, and treadmill walking can improve menstrual related pain and quality of life. Mindfulness is the non-judgmental acceptance and investigation of present experience, including body sensations, internal mental states, thoughts, emotions, impulses, and memories to reduce suffering or distress and to increase well-being. Prior research by our group has demonstrated efficacy of mindfulness meditation in reducing pain and improving quality of life in women with chronic pelvic pain. Mindful movement is putting attention into what the body is feeling as it moves. It involves paying attention movement that feels good as well as to early warning signs that an exercise may be too intense or may cause a pain flare.

This study is a 12-week program of gentle aerobic exercise and stretching for patients with CPP that applies mindful movement practices. Patients will be randomized to weekly classes versus the routine recommendations for exercise. We will measure pain reduction, improvement in quality of life, and reduction in pain catastrophizing and kinesiophobia.

详细描述

Chronic pelvic pain (CPP) is defined as the sensation of pain arising from the lower urinary tract, bowel, pelvic floor, myofascial, and reproductive structures and includes cyclic pain and pain with intercourse, when the condition adversely affects a patient's wellbeing. Chronic pelvic pain is often associated with negative cognitive, behavioral,sexual and emotional consequences, which can include physical deconditioning, pain catastrophizing, kinesiophobia, and depression. CPP has been estimated to affect between 5.7%-26.6% of women.

Treatments for pelvic pain include management of peripheral pain sources, as well as targeting the centrally mediated response to pain. The use of centrally acting pain medications, including opioids, is common in patients with pelvic pain. There is increasing literature recommending against the use of opioids for chronic pain, citing risks of dependence, addiction, and over-dose related death. Therefore, it is critical to look for safe alternatives to manage chronic pelvic pain.

Exercise has been targeted as a treatment strategy for chronic pain conditions, improving both pain intensity and physical function. Multiple studies have demonstrated that yoga, Zumba®, and treadmill walking can improve menstrual-related pain in young women with dysmenorrhea. In addition to pain reduction, studies have also demonstrated improvement in quality of life. Mindfulness is the non-judgmental acceptance and investigation of present experience, including body sensations, internal mental states, thoughts, emotions, impulses, and memories to reduce suffering or distress and to increase well-being. Prior research by our group has demonstrated efficacy of mindfulness meditation in reducing pain and improving quality of life in women with chronic pelvic pain. Mindful movement is putting attention into what the body is feeling as it moves. It involves paying attention movement that feels good as well as to early warning signs that an exercise may be too intense or may cause a pain flare.

This study is a 12-week program of aerobic exercise and stretching for patients with CPP that applies mindful movement practices. Patients will be randomized to weekly classes versus routine recommendations for exercise. We will measure pain reduction, improvement in quality of life, and reduction in pain catastrophizing and kinesiophobia.

We will enroll patients with chronic pelvic pain of at least 6-months duration who have not engaged in regular physical activity in the prior 3 months. Patients aged 18 or older receiving care in the Pelvic Pain Program at the WMC will be invited to take part in the study. Records for patients in the pelvic pain program who are presenting for care will be reviewed for eligibility and approached prior to their visit about potentially participating in the study. Additionally, charts for patients active in the pelvic pain program will be reviewed for eligibility and the research assistant contact participants about participation in the study. If patients are interested in the study and do not have an upcoming office visit, they will be scheduled to come in to meet with the research assistant and be consented for the study. Subjects will also be consented at the time of their office visits.

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
None

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

  • Must receive care in the Pelvic Pain Program at the Women's Medicine Collaborative at Lifespan
  • Aged 18 or over
  • Able to ambulate independently
  • Not exercising regularly: defined by less than 30 minutes of aerobic exercise per week in the past 3 months.
  • Able to speak and understand conversational English. Written materials will be available in English and Spanish.

排除标准

  • Under age 18
  • Currently pregnant or up to 6 weeks postpartum
  • Medical conditions for which exercise is contraindicated
  • Major surgery within the past 12 weeks or planned within the next 12 weeks

结局指标

主要结局

Change in Kinesiophobia and Pain Catastrophizing

时间窗: 12 weeks

To determine if mindful movement can reduce kinesiophobia and pain catastrophizing in patients with CPP

Change in Pelvic Pain Level

时间窗: 12 weeks

To determine if mindful movement can reduce pain in a patient with CPP

Impact on Quality of Life

时间窗: 12 weeks

To determine if mindful movement can improve quality of life in patients with CPP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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Mindful Movement for Pelvic Pain | 临床试验