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A Randomized Trial

Daniel S. Rooks, ScD; Shiva Gautam, PhD; Matthew Romeling, BS; Martha L. Cross, BS; Diana Stratigakis, BA; Brittany Evans, BS; Don L. Goldenberg, MD; Maura D. Iversen, DPT, SD, MPH; Jeffrey N. Katz, MD, MS

Arch Intern Med. 2007;167(20):2192-2200.

Background  Self-management has increasingly been recommended as part of standard care for fibromyalgia, a common, poorly understood condition with limited treatment options. Data that assess popular self-management recommendations are scarce. We evaluated and compared the effectiveness of 4 common self-management treatments on function, symptoms, and self-efficacy in women with fibromyalgia.

Methods  A total of 207 women with confirmed fibromyalgia were recruited from September 16, 2002, through November 30, 2004, and randomly assigned to 16 weeks of (1) aerobic and flexibility exercise (AE); (2) strength training, aerobic, and flexibility exercise (ST); (3) the Fibromyalgia Self-Help Course (FSHC); or (4) a combination of ST and FSHC (ST-FSHC). The primary outcome was change in physical function from baseline to completion of the intervention. Secondary outcomes included social and emotional function, symptoms, and self-efficacy.

Results  Improvements in the mean Fibromyalgia Impact Questionnaire score in the 4 groups were –12.7 for the ST-FSHC group, –8.2 for the AE group, –6.6 for the ST group, and –0.3 for the FSHC group. The ST-FSHC group demonstrated greater improvement than the FSHC group (mean difference, –12.4; 95% confidence interval [CI], –23.1 to –1.7). The ST-FSHC (mean difference, 13.6; 95% CI, 2.3 to 24.9) and AE (mean difference, 13.1; 95% CI, 1.6 to 25.6) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey. Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC (14.8), AE (13.2), and ST (5.7) groups. Social function, mental health, fatigue, depression, and self-efficacy also improved. The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months.

Conclusions  Progressive walking, simple strength training movements, and stretching activities improve functional status, key symptoms, and self-efficacy in women with fibromyalgia actively being treated with medication. The benefits of exercise are enhanced when combined with targeted self-management education. Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia.

Trial Registration  clinicaltrials.gov Identifier: NCT00321659

Author Affiliations: Division of Rheumatology (Dr Rooks, Mr Romeling, and Mss Cross, Stratigakis, and Evans) and the General Clinical Research Center (Dr Gautam), Beth Israel Deaconess Medical Center; Division of Rheumatology, Newton Wellesley Hospital (Dr Goldenberg); Section of Clinical Sciences, Division of Rheumatology, Immunology, and Allergy (Drs Iversen and Katz), and Department of Orthopedic Surgery (Dr Katz), Brigham and Women's Hospital; Department of Medicine, Harvard Medical School (Drs Rooks, Iversen, and Katz); and the Graduate Programs in Physical Therapy, MGH Institute of Health Professions (Dr Iversen), Boston, Massachusetts. Dr Rooks is now with the Novartis Institutes for Biomedical Research, Inc, Cambridge, Massachusetts.

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