Pain Management Techniques for Fibromyalgia - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00086060

Purpose

Note: This study is still recruiting participants with fibromyalgia and no longer recruiting healthy participants.

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.

Condition	Intervention	Phase
Fibromyalgia	Behavioral: Exercise regimen Behavioral: Relaxation training Procedure: Functional magnetic resonance imaging (fMRI)	Phase I Phase II

MedlinePlus related topics: Exercise and Physical Fitness Fibromyalgia MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Locus of Pain Control: Neural Substrates and Modifiability

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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 ]

Estimated Enrollment:	100
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
1: Experimental Participants will receive relaxation training and standard care for FM	Behavioral: Relaxation training Procedure: Functional magnetic resonance imaging (fMRI)
2: Experimental Participants will receive an exerice regimen and standard care for FM	Behavioral: Exercise regimen Procedure: Functional magnetic resonance imaging (fMRI)
3: Active Comparator Participants will receive standard of care for FM	Procedure: Functional magnetic resonance imaging (fMRI)
4: No Intervention Health participants will act as a control	Procedure: Functional magnetic resonance imaging (fMRI)

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

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

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

Investigators

Principal Investigator:

David A. Williams, PhD

Chronic Pain and Fatigue Research Center, University of Michigan

More Information

Responsible Party:	( David A. Williams, PhD )
Study ID Numbers:	NIAMS-121, R01 AR050044-01A1
Study First Received:	June 22, 2004
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00086060
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Internal-External Control
Magnetic Resonance Imaging
fMRI
Exercise
Relaxation

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009