Determining How the Nervous System Processes Pain in Adults With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dane Cook, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00496886
First received: July 5, 2007
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition
Fibromyalgia
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Imaging the Cognitive Modulation of Pain

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Physical activity [ Time Frame: one week ] [ Designated as safety issue: No ]
    The study measures physical activity the week prior to brain imaging

  • Brain white matter [ Time Frame: single experimental session ] [ Designated as safety issue: No ]
    The study measures white matter using diffusion tensor imaging methods


Enrollment: 137
Study Start Date: April 2006
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community and primary care clinic samples.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496886

Locations
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Dane B. Cook, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Dane Cook, Associate Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00496886     History of Changes
Other Study ID Numbers: R01 AR050969, R01AR050969, 1 R01 AR050969-01A1
Study First Received: July 5, 2007
Last Updated: February 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
Pain
Nociception

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Fibromyalgia
Myofascial Pain Syndromes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 10, 2014