Pain Management Techniques for Fibromyalgia
Locus of Pain Control: Neural Substrates and Modifiability
2 other identifiers
interventional
97
1 country
1
Brief Summary
Pain management techniques may influence how the brain processes pain and may help patients with fibromyalgia (FM), a chronic pain condition. This study will train patients with FM to use pain management techniques. Investigators will use brain scanning (functional magnetic resonance imaging, or fMRI) technology to identify changes in how a patient's brain processes pain over time. This study is primarily interested in examining cortical response to different behavioral interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 22, 2004
CompletedFirst Posted
Study publicly available on registry
June 23, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedOctober 10, 2011
October 1, 2011
3.8 years
June 22, 2004
October 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in clinical pain
Measured at Week 8
Change in activation pattern in fMRI
Measured at Week 8
Change in locus of control
Measured at Week 8
Secondary Outcomes (3)
Improvement in symptoms
Measured at Week 8
Improvement in function
Measured at Week 8
Improvement in mood
Measured at Week 8
Study Arms (4)
1 - Relaxation Training
EXPERIMENTALParticipants will receive relaxation training and standard care for FM
2 Exercise Regimen
EXPERIMENTALParticipants will receive an exercise regimen and standard care for FM
3 Standard Care
ACTIVE COMPARATORParticipants will receive standard of care for FM
4 Health Controls
NO INTERVENTIONHealth participants will act as a control
Interventions
Aerobic Exercise is a self-management technique that increases personal control over pain by enhancing physical fitness. Patients will be encouraged to choose activities best suited to their tastes and current lifestyle, incorporating lifestyle physical activities (climbing stairs, household chores, etc) and more traditional exercise activities (walking, cycling, etc.). Subjects will use ratings of perceived exertion (RPE) to guide their effort. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for exercise, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Relaxation is a self-management technique that increases personal control over pain by relaxing tense muscles, allowing the body to rest, and improving mental clarity through concentration and attention and has a great deal of empirical research supporting its effectiveness as a means of pain management. A variety of relaxation skills will be taught with some being based on muscle relaxation, and others focused more on cognitive relaxation and imagery. The intervention will consist of two-hours of face-to-face contact followed by weekly telephone contact for 8 weeks. Face-to-face contract will include receiving a standardized instruction manual for relaxation, a demonstration on how to perform relaxation, and tailoring homework assignments to be monitored on the weekly phone call.
Participants in the standard care control group will not receive any additional intervention beyond that which they are receiving from their routine health care professional.
Eligibility Criteria
You may qualify if:
- Diagnosis of fibromyalgia based on the criteria outlined by the American College of Rheumatology
- Standard medical care for fibromyalgia with the referring physician for at least the past 3 months
You may not qualify if:
- Severe physical impairment that would prevent the participant from receiving either of the nondrug interventions (e.g., complete blindness, deafness, paraplegia) or coexisting physical impairments that could be harmed by light exercise (e.g., sprained ankle, neck injury)
- Morbid obesity
- Autoimmune disease
- Cardiopulmonary disorders (e.g., angina, congestive heart failure, COPD, chronic asthma)
- Uncontrolled endocrine or allergic disorders (e.g., thyroid dysfunction, Type I diabetes)
- Cancer within the past 2 years
- Current psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder), current suicide risk or suicide attempt within 2 years of study entry, or substance abuse within 2 years of study entry. Participants with mood disorders will not be excluded.
- Any pending or active disability associated with fibromyalgia (e.g., SSI, Workers' Compensation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chronic Pain and Fatigue Research Center, University of Michigan
Ann Arbor, Michigan, 48106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A. Williams, PhD
Chronic Pain and Fatigue Research Center, University of Michigan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2004
First Posted
June 23, 2004
Study Start
May 1, 2004
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
October 10, 2011
Record last verified: 2011-10