Nondrug Treatment Programs for Adults With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Behavioral Preparation for Treating Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088777
• Other study ID #: 9345
• Secondary ID: 5R01AR048888-06R
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: August 10, 2011
• Start date: January 2005
• Est. completion date: April 2010

Study information

• Verified date: August 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Behavioral coping skills training plus physical therapy
10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education
• Stress management education plus physical therapy
10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education

Locations

Country	Name	City	State
United States	University of Utah, Pain Research and Management Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations		post-treatment, 6 month and 12 month follow-ups	No