Nondrug Treatment Programs for Adults With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00088777
First received: August 4, 2004
Last updated: August 10, 2011
Last verified: August 2011

August 4, 2004
August 10, 2011
January 2005
April 2010   (final data collection date for primary outcome measure)
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 ]
Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations
Complete list of historical versions of study NCT00088777 on ClinicalTrials.gov Archive Site
Not Provided
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Nondrug Treatment Programs for Adults With Fibromyalgia
Behavioral Preparation for Treating Fibromyalgia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Behavioral: Behavioral coping skills training plus physical therapy
    10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
  • Behavioral: Stress management education plus physical therapy
    10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education
  • Experimental: MET
    Intervention: Behavioral: Behavioral coping skills training plus physical therapy
  • Experimental: CSE
    Intervention: Behavioral: Stress management education plus physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2010
April 2010   (final data collection date for primary outcome measure)

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)
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00088777
9345, 5R01AR048888-06, R01 AR048888-01A2
Not Provided
Akiko Okifuji, University of utah
University of Utah
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Akiko Okifuji, PhD University of Utah, Pain Research and Management Center
University of Utah
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP