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Pain Management Techniques for Fibromyalgia
This study is not yet open for patient recruitment.
Sponsored by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Purpose
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Investigators will use brain scanning (functional magnetic resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes pain over time.
Condition | Treatment or Intervention | Phase |
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Fibromyalgia |
Behavior: Exercise regimen Behavior: Relaxation training Procedure: Functional magnetic resonance imaging (fMRI) |
Phase I Phase II |
MedlinePlus related topics: Fibromyalgia
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Locus of Pain Control: Neural Substrates and Modifiability
Expected Total Enrollment: 100
FM is a chronic pain condition that has no cure, and drugs are only partially successful in managing its symptoms. Many people with FM utilize nondrug management methods, such as exercise, for symptom relief. Nondrug methods can be quite effective, but some patients find it difficult to use these methods consistently. This study will determine which nondrug methods relieve FM symptoms by examining patients' brains after exercise or relaxation techniques. Preliminary data indicate that beliefs about one’s personal ability to control pain result in use of differential neural mechanisms to process pain. This study will use fMRI, a tool for visualizing pain-processing patterns, to gain insights into how exercise and relaxation techniques modify pain processing in patients with FM.
There are four arms in this study. All participants with FM will be randomly assigned to one of three study arms. Participants in Arm 1 will receive relaxation training to supplement standard care for FM. Arm 2 participants will be prescribed an exercise regimen to supplement standard care. Participants in Arm 3 will receive standard care only. Arm 4 is a healthy control group, which will be followed during the 8-week intervention period.
At baseline, all participants will undergo blood collection and physical examination and will complete questionnaires about demographics, treatment history, symptoms, functional status, affective status, and beliefs about pain. They will also undergo a baseline fMRI imaging study, combined with evoked pressure pain testing, to evaluate differences in neural mechanisms involved in pain processing. Patients in Arms 1 and 2 will then attend one face-to-face training session with a therapist, followed by phone contact over the next 8 weeks. Participants will be asked to record pain and adherence to treatment on an electronic diary. After 8 weeks, all study participants will undergo a second fMRI scan, blood collection, and physical examination, and will complete questionnaires similar to those completed at baseline.
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria for Arms 1, 2, and 3:
Exclusion Criteria for All Participants:
Location Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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