Clinical trial NCT00496886: Determining How the Nervous System Processes Pain in Adults With Fibromyalgia
Official title: Imaging the Cognitive Modulation of Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Rheumatoid Arthritis
Keywords: Pain
Nociception
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-07-06
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community and primary care clinic samples.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain responses to pain
timeFrame: Single experimental session
Secondary outcomes:
measure: Physical activity
timeFrame: one week
measure: Brain white matter
timeFrame: single experimental session
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Dane B. Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: