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Completed

NCT Number: NCT00496886

Determining How the Nervous System Processes Pain in Adults With Fibromyalgia

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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Key information

Conditions

Fibromyalgia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Physical activity

    Time frame: one week

    The study measures physical activity the week prior to brain imaging

  2. Brain white matter

    Time frame: single experimental session

    The study measures white matter using diffusion tensor imaging methods

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Imaging the Cognitive Modulation of Pain

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Jul 6, 2007
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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