Pain Management Techniques for Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Behavioral: Exercise regimenBehavioral: Standard CareBehavioral: Relaxation training
- Registration Number
- NCT00086060
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Exercise Regimen Exercise regimen Participants will receive an exercise regimen and standard care for FM 3 Standard Care Standard Care Participants will receive standard of care for FM 1 - Relaxation Training Relaxation training Participants will receive relaxation training and standard care for FM
- Primary Outcome Measures
Name Time Method Change in clinical pain Measured at Week 8 Change in activation pattern in fMRI Measured at Week 8 Change in locus of control Measured at Week 8
- Secondary Outcome Measures
Name Time Method Improvement in symptoms Measured at Week 8 Improvement in function Measured at Week 8 Improvement in mood Measured at Week 8
Trial Locations
- Locations (1)
Chronic Pain and Fatigue Research Center, University of Michigan
🇺🇸Ann Arbor, Michigan, United States