Determining How the Nervous System Processes Pain in Adults With Fibromyalgia

Rheumatoid Arthritis Clinical Trial

Official title:

Imaging the Cognitive Modulation of Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496886
• Other study ID #: R01AR050969
• Secondary ID: R01AR0509691R01A
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: October 1, 2015
• Start date: April 2006
• Est. completion date: June 2011

Study information

• Verified date: February 2013
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Fibromyalgia
• Myofascial Pain Syndromes
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain responses to pain	The study determines brain responses to pain in both healthy participants and those with fibromyalgia under conditions designed to manipulate anticipation and attention.	Single experimental session	No
Secondary	Physical activity	The study measures physical activity the week prior to brain imaging	one week	No
Secondary	Brain white matter	The study measures white matter using diffusion tensor imaging methods	single experimental session	No