Optimizing Fibromyalgia Self-management
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The overall objective of this work is to improve treatment outcomes for persons with
      fibromyalgia by optimizing the approach to self-management. The purpose of this research
      project is to evaluate and compare, in a randomized, controlled trial involving 200 women,
      the short and long-term effectiveness of four approaches to fibromyalgia self-management for
      improving health and functional status, self-efficacy, and symptom severity. Additionally, we
      will also examine the effect of each intervention on health care usage. We will assess the
      following 16-week interventions:

        -  cardiovascular and flexibility exercise

        -  strength training, cardiovascular and flexibility exercise

        -  Arthritis Foundation's Fibromyalgia Self-Help course

        -  a combination of the Fibromyalgia Self-Help Course and strength training exercise
           interventions
    

Detailed description: 
      Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause
      of disability and increased health care utilization. Current treatment focuses largely on
      pharmacological interventions, which are often ineffective at improving symptoms and
      functional status. Recent research suggests that disease self-management can be efficacious
      in the short-term at reducing symptom severity and improving function in persons with FMS.
      The most common forms of FMS self-management are coping skills training
      (behavioral/education) and exercise. Limited in number, most FMS self-management studies
      examine the short-term effects of one form or the other, with most using the coping skills
      training approach. Little data exist to examine the long-term effects of these interventions,
      the potential additive effect of combining coping skills training with a comprehensive, group
      exercise program or an approach for promoting long-term compliance of these interventions.
      The objective of this proposal is to identify the optimal approach to FMS self-management.
      The study is a randomized, controlled trial comparing coping skills training (the Arthritis
      Foundation Fibromyalgia Self-Help Course (FSHC)) with two exercise programs - cardiovascular
      and flexibility training with and without strength training - and a combination (the FSHC
      plus the strength training exercise program). Each intervention period will last 16 weeks and
      include group sessions led by trained personnel. Subjects will be followed for 6 months after
      completing the intervention to evaluate the short-term effect of each program. At 6 months,
      subjects will be randomized into two groups-one group will receive a 4 week refresher course
      of their original intervention every 6 months and the other group will receive no further
      intervention. Long-term follow up will be for 24 months after completing the 16 week
      intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old
      with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth
      Israel Deaconess Medical Center's GCRC at five time points-baseline, completion of the
      16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional
      status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis
      Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and
      health care utilization (direct and indirect costs). The study will improve treatment
      outcomes for persons with FMS by identifying the optimal self-management program.
    

Intervention name(s): Aerobic; Strength training; Combination; FSHC
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 3x/week of walking and cycling; 3x/week of resistance training activities; 3x/week of aerobic and strength training activities; Biweekly group education group meetings
Other intervention name(s): Fibromyalgia Self-Help Course
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; self-management; exercise; patient education