BACKGROUND AND OBJECTIVE
Affect and how it is regulated plays a role in pain perception, maintenance of pain, and its resolution. This randomized, controlled trial evaluated an innovative affective self-awareness (ASA) intervention, which was designed to reduce pain and improve functioning in individuals with fibromyalgia.
PARTICIPANTS AND METHODS
Forty-five women with fibromyalgia were randomized to a manualized ASA intervention (n = 24) or wait-list control (n = 21). The intervention began with a one-time physician consultation, followed by 3 weekly, 2-h group sessions based upon a mind-body model of pain. Sessions focused on structured written emotional disclosure and emotional awareness exercises. Outcomes in both conditions were measured by a blinded assessor at baseline, post-intervention, and 6-month follow-up.
The primary outcome was pain severity (Brief Pain Inventory); secondary outcomes included tender-point threshold and physical function (SF-36 Physical Component Summary). Intent-to-treat analyses compared groups on outcomes using analysis of covariance and on the proportion of patients achieving ≥30% and ≥50% pain reduction at 6 months.
Adjusting for baseline scores, the intervention group had significantly lower pain severity (p < 0.001), higher self-reported physical function (p < 0.001), and higher tender-point threshold (p = 0.02) at 6 months compared to the control group. From baseline to 6 months, 45.8% of the ASA intervention group had ≥30% reduction in pain severity, compared to none of the controls (p < 0.001).
The affective self-awareness intervention improved pain, tenderness, and self-reported physical function for at least 6 months in women with fibromyalgia compared to wait-list control. This study suggests the value of interventions targeting emotional processes in fibromyalgia, although further studies should evaluate the efficacy of this intervention relative to active controls.
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Our research was supported in part by the Scott F. Nadler, DO, Research Grant (Physiatric Association of Spine, Sports, and Occupational Rehabilitation); and by grant numbers U020912 (Michigan Institute of Clinical and Health Research); T32-HD007422, K12HD001097 (NICHD/NIH); AR049059, (NIAMS/NIH); and DAMD 17-00-2-0018 (Department of Defense).
These data were presented at the American Academy of Physical Medicine and Rehabilitation; November 22, 2008; San Diego, CA, and the North American Research Council for Complementary and Integrative Medicine, May 14, 2009, Minneapolis, MN.
Conflict of interest statement
There is one potential conflict of interest to report. Dr. Schubiner developed the program used in this study. He conducts this program at Providence Hospital and on the Internet. It is unlikely that this was a significant factor in this study since Dr. Hsu, who performed all of the baseline and outcome assessments and all data analyses, remained a blinded assessor throughout the study.
Supported in part by the Scott F. Nadler, DO, Research Grant (Physiatric Association of Spine, Sports, and Occupational Rehabilitation) and by grant numbers U020912 (Michigan Institute of Clinical and Health Research); T32-HD007422, K12HD001097 (NICHD/NIH); AR049059 (NIAMS/NIH); and DAMD 17-00-2-0018 (Department of Defense).
Clinicaltrials.gov identifier NCT00437411
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Hsu, M.C., Schubiner, H., Lumley, M.A. et al. Sustained Pain Reduction Through Affective Self-awareness in Fibromyalgia: A Randomized Controlled Trial. J GEN INTERN MED 25, 1064–1070 (2010). https://doi.org/10.1007/s11606-010-1418-6
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