Pain Management Techniques for Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David A. Williams, University of Michigan
ClinicalTrials.gov Identifier:
NCT00086060
First received: June 22, 2004
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Behavioral: Exercise regimen
Behavioral: Relaxation training
Behavioral: Standard Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Locus of Pain Control: Neural Substrates and Modifiability

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in clinical pain [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Change in activation pattern in fMRI [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Change in locus of control [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in symptoms [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Improvement in function [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
  • Improvement in mood [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: May 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Relaxation Training
Participants will receive relaxation training and standard care for FM
Behavioral: Relaxation training
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.
Experimental: 2 Exercise Regimen
Participants will receive an exercise regimen and standard care for FM
Behavioral: Exercise regimen
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.
Active Comparator: 3 Standard Care
Participants will receive standard of care for FM
Behavioral: Standard Care
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.
No Intervention: 4 Health Controls
Health participants will act as a control

Detailed Description:

FM is a chronic pain condition that has no cure, and drugs are only partially successful in managing its symptoms. Many people with FM utilize nondrug management methods, such as exercise, for symptom relief. Nondrug methods can be quite effective, but some patients find it difficult to use these methods consistently. This study will determine which nondrug methods relieve FM symptoms by examining patients' brains after exercise or relaxation techniques. Preliminary data indicate that beliefs about one's personal ability to control pain result in use of differential neural mechanisms to process pain. This study will use fMRI, a tool for visualizing pain-processing patterns, to gain insights into how exercise and relaxation techniques modify pain processing in patients with FM.

There are four arms in this study. All participants with FM will be randomly assigned to one of three study arms. Participants in Arm 1 will receive relaxation training to supplement standard care for FM. Arm 2 participants will be prescribed an exercise regimen to supplement standard care. Participants in Arm 3 will receive standard care only. Arm 4 is a healthy control group, which will be followed during the 8-week intervention period.

At baseline, all participants will undergo blood collection and physical examination and will complete questionnaires about demographics, treatment history, symptoms, functional status, affective status, and beliefs about pain. They will also undergo a baseline fMRI imaging study, combined with evoked pressure pain testing, to evaluate differences in neural mechanisms involved in pain processing. Patients in Arms 1 and 2 will then attend one face-to-face training session with a therapist, followed by phone contact over the next 8 weeks. Participants will be asked to record pain and adherence to treatment on an electronic diary. After 8 weeks, all study participants will undergo a second fMRI scan, blood collection, and physical examination, and will complete questionnaires similar to those completed at baseline.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Note: Given that this study requires participation in a number of appointments and reimbursement will not be made for travel expenses, individuals residing more than 100 miles from Ann Arbor are not encouraged to participate in this project.

Inclusion Criteria for Arms 1, 2, and 3:

  • 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

Exclusion Criteria for All Participants:

  • 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)
  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: NCT00086060

Locations
United States, Michigan
Chronic Pain and Fatigue Research Center, University of Michigan
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: David A. Williams, PhD Chronic Pain and Fatigue Research Center, University of Michigan
  More Information

No publications provided

Responsible Party: David A. Williams, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00086060     History of Changes
Other Study ID Numbers: NIAMS-121, R01AR050044-01A1, R01 AR050044-01A1
Study First Received: June 22, 2004
Last Updated: October 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Internal-External Control
Magnetic Resonance Imaging
fMRI
Exercise
Relaxation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014