Determining How the Nervous System Processes Pain in Adults With Fibromyalgia
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| First Received Date ICMJE | July 5, 2007 | ||||
| Last Updated Date | February 26, 2013 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Brain responses to pain [ Time Frame: Single experimental session ] [ Designated as safety issue: No ] 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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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00496886 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determining How the Nervous System Processes Pain in Adults With Fibromyalgia | ||||
| Official Title ICMJE | Imaging the Cognitive Modulation of Pain | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Community and primary care clinic samples. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 137 | ||||
| Completion Date | June 2011 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00496886 | ||||
| Other Study ID Numbers ICMJE | R01 AR050969, R01AR050969, 1 R01 AR050969-01A1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dane Cook, University of Wisconsin, Madison | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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