Determining How the Nervous System Processes Pain in Adults With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00496886|
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : October 2, 2015
|Condition or disease|
|Fibromyalgia Rheumatoid Arthritis|
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.
|Study Type :||Observational|
|Actual Enrollment :||137 participants|
|Observational Model:||Case Control|
|Official Title:||Imaging the Cognitive Modulation of Pain|
|Study Start Date :||April 2006|
|Primary Completion Date :||June 2010|
|Study Completion Date :||June 2011|
- Brain responses to pain [ Time Frame: Single experimental session ]The study determines brain responses to pain in both healthy participants and those with fibromyalgia under conditions designed to manipulate anticipation and attention.
- Physical activity [ Time Frame: one week ]The study measures physical activity the week prior to brain imaging
- Brain white matter [ Time Frame: single experimental session ]The study measures white matter using diffusion tensor imaging methods
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496886
|United States, Wisconsin|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53706|
|Principal Investigator:||Dane B. Cook, PhD||University of Wisconsin, Madison|