Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this proposal is to evaluate the efficacy of a multiple component mind-body
      (MCMB) therapy for fibromyalgia, both in short and long term outcomes. Preliminary work
      suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al
      1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB
      intervention or a 12 week education/attention intervention. The primary aims of this study
      are 1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks)
      outcomes in FM patients compared to an education/attention control group; and 2) to determine
      if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM patients
      compared to an education/attention control group.

      A secondary aim of this project involves determining if there are patient characteristics
      (i.e. disease severity and duration, demographics, psychological factors) associated with
      improvements in short or long term outcomes as well as responses to the MCMB intervention.

      The primary outcome measure will include physical functioning and pain as measured by the
      Fibromyalgia Impact Questionnaire.
    

Detailed description: 
      Fibromyalgia (FM) is a common, complex and chronic condition of unknown etiology (Carette
      1994). It is characterized by widespread musculoskeletal pain, multiple tender points,
      fatigue and a range of other symptoms (Wolfe 1990). FM accounts for 15% of rheumatology
      consultations, with a prevalence of 2% in the general population (3.4% in females and 0.5% in
      males), rising to 7% in the elderly females (Wolfe 1995). Disability levels in social and
      work roles, as well as use of medical care, is high. Current treatment options often meet
      with limited success.

      The goal of this proposal is to evaluate the efficacy of a multiple component mind-body
      (MCMB)therapy for fibromyalgia, both in short and long term outcomes. Preliminary work
      suggests that FM patients do benefit from MCMB therapy (Singh et al 1998; Creamer et al
      1998). This two-arm clinical trial will randomize 110 patients to either a 12 week MCMB
      intervention or a 12 week education/attention intervention. The primary aims of this study
      are (1) to determine if a 12 week MCMB intervention improves short term (i.e. at 12 weeks)
      outcomes in FM patients compared to an education/attention control group; and (2) to
      determine if a 12 week MCMB intervention improves long term (i.e. at 24 weeks) outcomes in FM
      patients compared to an education/attention control group.

      A secondary aim of this project involves determining if there are patient characteristics
      (i.e. disease severity and duration, demographics, psychological factors) associated with
      improvements in short or long term outcomes as well as responses to the MCMB intervention.

      The primary outcome measure will include physical functioning and pain as measured by the
      Fibromyalgia Impact Questionnaire.
    

Intervention name(s): Multiple Component Mind/Body therapy
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment