Nondrug Treatment Programs for Adults With 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:	NCT00088777

Purpose

Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug treatment. This study will compare the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education in relieving the symptoms of FM. Each of these nondrug treatments will be combined with physical therapy and physical education.

Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition, compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2) Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in treatment responses to delineate who will benefit most from each type of the behavioral preparation programs.

Condition	Intervention	Phase
Fibromyalgia	Behavioral: Behavioral coping skills training plus physical therapy Behavioral: Stress management education plus physical therapy	Phase II

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Behavioral Preparation for Treating Fibromyalgia

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

Primary Outcome Measures:

Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations [ Time Frame: post-treatment, 6 month and 12 month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2005
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MET: Experimental	Behavioral: Behavioral coping skills training plus physical therapy 10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
CSE: Experimental	Behavioral: Stress management education plus physical therapy 10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education

Detailed Description:

FM is a chronic pain condition causing discomfort and disability; there is no known cure. Research suggests that combination treatment of physical therapy, fibromyalgia education, and stress management education is helpful for many patients with this condition. However, how much benefit patients get from such therapies varies greatly. This study will evaluate the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education each in combination with physical therapy and physical education, in relieving the symptoms of FM.

The study will last approximately 15 months. Participants will undergo a comprehensive assessment including medical, physical, and psychological evaluations. Blood will be collected to measure participants' serotonin levels; participants will also be asked to complete several questionnaires to assess their FM symptoms and joint function. For a 7-day period prior to starting behavioral interventions, participants will be asked to carry a personal-size digit assistant (PDA) that will ask them questions about their quality of life three times a day . During this time, they will also continuously wear a wristwatch-like device to measure functional movement and quality of sleep.

For 10 weeks, participants will undergo therapy sessions of one of the behavioral interventions (behavioral preparation, stress management education, or fibromyalgia and coping education) along with physical therapy and physical education. During Weeks 1 through 4, participants will receive 2 hours of their assigned intervention. During Weeks 5 and 6, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy. During Weeks 7 through 9, they will receive 1 hour of physical therapy and 1 hour of physical education. During Week 10, they will receive 1 hour of their assigned intervention and 1 hour of physical therapy.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of fibromyalgia
Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week

Exclusion Criteria:

Other progressive disease
Plan to have surgery during the next year
Pregnancy or planning to become pregnant during the next year
Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg
Cardiovascular diseases
Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year)
Non-IV substance abuse within the last 2 years, or history of recreational IV drug use
Other rheumatologic disorder (e.g., rheumatoid arthritis)
Neuropathic pain
Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088777

Locations

United States, Utah
University of Utah, Pain Research and Management Center	Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Reiko Mitsunaga, RN 810-585-7695 pain.research@hsc.utah.edu
Principal Investigator: Akiko Okifuji, PhD

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Akiko Okifuji, PhD

University of Utah, Pain Research and Management Center

More Information

Responsible Party:	University of utah ( Akiko Okifuji )
Study ID Numbers:	NIAMS-119, R01 AR048888-01A2
Study First Received:	August 4, 2004
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00088777
Health Authority:	United States: Federal Government

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 14, 2009