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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) |
ClinicalTrials.gov Identifier: | NCT00496886 |
Fibromyalgia (FM) is a disabling chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points, specific places on the body that become painful with only slight pressure. Pain associated with FM cannot be explained medically, often leading to a delayed diagnosis and delayed treatment. The purpose of this study is to evaluate how the nervous system, specifically the brain, processes pain in women with FM.
Condition |
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Fibromyalgia Rheumatoid Arthritis |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Imaging the Cognitive Modulation of Pain |
Estimated Enrollment: | 120 |
Study Start Date: | April 2006 |
The cause of FM remains unknown, and more than half of all FM patients do not experience adequate pain relief from current treatment. Identifying the mechanisms of unexplained pain in people with FM is necessary to develop more beneficial treatments. One possible cause of FM may be associated with problems in how the body processes pain. People with FM appear to be hypersensitive to stimuli that normally are not painful. Specifically, the brain and spinal cord may not signal sensations correctly, resulting in abnormal pain sensations. This study will use functional magnetic resonance imaging (fMRI) to examine how pain is processed in the brain of adults with FM compared with adults with rheumatoid arthritis (RA), another chronic disease characterized by long-term pain with a known cause. This study will also determine the effect that anticipation and attention have on the processing of nonpainful stimuli in women with FM and RA. Both groups of people will also be compared to a control group of healthy people.
Participants in this study will include only women. This study will include two study visits that will occur on separate days. Each study visit will last from 2 to 3 hours. During the first study visit, participants will complete questionnaires. They will then rate heat stimuli applied to their hand and perform mental tasks while in a mock MRI machine. The mental tasks will consist of naming the color of words. Some participants will receive nonpainful heat stimuli; others will receive both painful and nonpainful heat stimuli. During the second study visit, participants will undergo the exact same procedures while in an actual MRI machine. There will be no follow-up visits for this study.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Community and primary care clinic samples.
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin - Madison | |
Madison, Wisconsin, United States, 53706 |
Principal Investigator: | Dane B. Cook, PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin-Madison ( Dane B. Cook ) |
Study ID Numbers: | R01 AR050969, 1 R01 AR050969-01A1 |
Study First Received: | July 5, 2007 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00496886 History of Changes |
Health Authority: | United States: Federal Government |
Pain Nociception |
Muscular Diseases Autoimmune Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Fibromyalgia |
Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Pain Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Fibromyalgia Myofascial Pain Syndromes Joint Diseases Nervous System Diseases Arthritis, Rheumatoid |
Rheumatic Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Arthritis Connective Tissue Diseases |