Fibromyalgia Clinical Trial
Official title:
Locus of Pain Control: Neural Substrates and Modifiability
Verified date | October 2011 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Note: Given that this study requires participation in a number of appointments and
reimbursement will not be made for travel expenses, individuals residing more than 100
miles from Ann Arbor are not encouraged to participate in this project. Inclusion Criteria for Arms 1, 2, and 3: - Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology - Standard medical care for fibromyalgia with the referring physician for at least the past 3 months Exclusion Criteria for All Participants: - Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury) - Morbid obesity - Autoimmune disease - Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma) - Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes) - Cancer within the past 2 years - Current psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder), current suicide risk or suicide attempt within 2 years of study entry, or substance abuse within 2 years of study entry. Participants with mood disorders will not be excluded. - Any pending or active disability associated with fibromyalgia (e.g., SSI, Workers' Compensation) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Chronic Pain and Fatigue Research Center, University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in clinical pain | Measured at Week 8 | No | |
Primary | Change in activation pattern in fMRI | Measured at Week 8 | No | |
Primary | Change in locus of control | Measured at Week 8 | No | |
Secondary | Improvement in symptoms | Measured at Week 8 | No | |
Secondary | Improvement in function | Measured at Week 8 | No | |
Secondary | Improvement in mood | Measured at Week 8 | No |
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