Fibromyalgia Clinical Trial
Official title:
Locus of Pain Control: Neural Substrates and Modifiability
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. This study is primarily interested in examining cortical response to different behavioral interventions.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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