Determining How the Nervous System Processes Pain in Adults With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496886
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : October 2, 2015
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Wisconsin, Madison

July 5, 2007
July 6, 2007
October 2, 2015
April 2006
June 2010   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00496886 on Archive Site
  • 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
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Determining How the Nervous System Processes Pain in Adults With Fibromyalgia
Imaging the Cognitive Modulation of Pain
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.

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.

Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample
Community and primary care clinic samples.
  • Fibromyalgia
  • Rheumatoid Arthritis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of FM or RA OR healthy
  • Right-handed

Exclusion Criteria:

  • Diagnosis of depression
  • Using illegal drugs
  • Claustrophobic
  • Metal objects in body
  • Require cardiovascular, high-dose antidepressant, or certain analgesic medications
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01AR050969( U.S. NIH Grant/Contract )
R01AR050969 ( U.S. NIH Grant/Contract )
1R01AR050969-01A1 ( U.S. NIH Grant/Contract )
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University of Wisconsin, Madison
University of Wisconsin, Madison
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Dane B. Cook, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2013