Endometriosis Clinical Trial
Official title:
A Randomized Clinical Trial of Mindful Movement for Patients With Chronic Pelvic
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Miriam Hospital | Rhode Island Foundation |
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pelvic Pain Level | To determine if mindful movement can reduce pain in a patient with CPP | 12 weeks | |
Primary | Impact on Quality of Life | To determine if mindful movement can improve quality of life in patients with CPP | 12 weeks | |
Primary | Change in Kinesiophobia and Pain Catastrophizing | To determine if mindful movement can reduce kinesiophobia and pain catastrophizing in patients with CPP | 12 weeks |
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