ASA for Fibromyalgia? It's Not What You Think
Abstract & Commentary
By Nancy Selfridge, MD. Dr. Selfridge is Associate Professor, Department of Integrated Medical Education, Ross University School of Medicine, Commonwealth of Dominica, West Indies; she reports no financial relationship to this field of study.
Synopsis: Women with fibromyalgia participated in a treatment protocol consisting of an educational consultation with a physician, followed by group activities focusing on structured written emotional disclosure and emotional awareness exercises. The treatment group was compared to a wait-list control group of fibromyalgia patients. The affective self-awareness (ASA) intervention significantly improved pain, tenderness, and physical function for at least 6 months in the treatment group compared to the wait-list control group.
Source: Hsu M, et al. Sustained pain reduction through affective self-awareness in fibromyalgia: A randomized controlled trial. J Gen Intern Med 2010 Jun 8; doi: 10.1007/s11606-0101418-6.
The investigators in this study set out to determine if an intervention program targeted at raising emotional self-awareness could mitigate pain and improve function in fibromyalgia patients. Forty-five women with fibromyalgia were randomized to either an intervention group (n = 24) or a wait-list control group (n = 21). Participants were screened with an interview and 2-hour history and physical examination evaluation performed by a physical medicine and rehabilitation specialist to confirm the diagnosis of fibromyalgia, based on the 1990 ACR criteria (Wolfe et al).1 Exclusion criteria were few: serious medical comorbidities; current, serious psychiatric disorders, suicide risk, or substance abuse; changes in pain medication within 1 month prior to enrollment.
Subjects were randomized to the intervention or wait-list groups and the assessor remained blinded to the group assignments for the 6-month study period. The two groups were compared at baseline and did not differ in demographics, age, duration of symptoms, disability status, educational level, affective disorder comorbidities, or past treatment. The treatment group did report greater baseline pain severity, fatigue, health-related physical disability and sleep problems than the control group.
The study intervention consisted of a 90-minute individualized physician consultation, reviewing the participant's medical and psychosocial history and identifying links between life stressors, emotional responses, and both onset and exacerbations of fibromyalgia symptoms. Pain experiences were validated by the physician and a mind-body model for understanding pain was offered. Participants were asked to read a book, The Mindbody Prescription, by John Sarno, MD, to reinforce understanding of the proffered model.2 Participants then attended three 2-hour small group sessions with the consultation physician as facilitator/moderator. The sessions focused on education to reinforce a biopsychosocial model for chronic pain; emotional disclosure writing exercises about stressors; affective awareness techniques; and re-engagement in previously avoided activities. In addition to the group sessions, homework consisted of daily writing assignments and daily CD-guided exercises focusing on mindfulness of breath, body, and emotions, and affirmations of self-acceptance and self-healing. After the final group session, the physician facilitator contacted each participant for a 15-20 minute phone call to address remaining concerns and to encourage continued practice. Individuals in the wait-list group were free to pursue interventions on their own and were invited to participate in the ASA intervention after the 6-month waiting period.
The primary outcome measure was pain severity, rated by the Brief Pain Inventory (BPI) Pain Severity instrument. Secondary pain outcomes were also measured. Number of painful body regions and interference of pain on daily tasks were measured by additional BPI instruments. Tender-point threshold was measured using a modified dolorimeter. Health-related physical and mental functioning was measured using the SF-36 inventory. Additional outcomes were fatigue, sleep disturbance, and beliefs about pain control, and were measured with a variety of previously validated assessment instruments.
Data were analyzed at baseline, post-intervention for treatment subjects or 6 weeks post-randomization for controls, and at 6 months post-randomization for all study subjects. Tender-point threshold was measured twice: at baseline and 6 months post-randomization.
Only three patients in the treatment group withdrew after the initial consultation because of scheduling difficulties. There were no other dropouts in either the intervention or control groups. Outcomes were subjected to intent-to-treat analyses using the last observation carried forward for the three patients who withdrew. Analysis of covariance (ANCOVA) was also applied to outcomes using the baseline score as the covariate, a decision that was supported by the greater baseline scores for pain severity, etc., noted in the treatment group.
The ASA treatment group reported significantly lower pain severity, both immediately post-treatment and at 6-month follow-up, than did the wait-list group. At 6 months, 45.8% of the treatment group had at least 30% reduction in pain and 20.8% had at least 50% reduction in pain. None of the wait-list control group reported any reduction in pain. For secondary outcomes, the ASA treatment group also showed significant improvement compared to wait-list controls, except for mental function and sleep disturbance. To address the issue of regression to the mean for the treatment group patients who had worse baseline scores, ANCOVAs were repeated after removing outliers from the analysis. This allowed the authors to conclude that baseline differences did not account for the positive effect of the intervention.
Commentary
Despite new pharmaceutical treatments promoted for fibromyalgia, this chronic widespread pain syndrome remains difficult to manage, as at least 50% of patients fail to demonstrate a therapeutic response.
The authors have to be applauded for this carefully constructed study and subsequent analysis. Few interventions for fibromyalgia have been shown to result in this kind of improvement in pain and physical function. The effect size of this study is larger than that seen in two previous FM studies using written emotional disclosure treatments.3,4 The authors postulate that this may be because the ASA treatment protocol in this study included significant didactic education about the role of emotions in pain experience, mindfulness exercises, more intensive writing exercises, and a group format. In addition, the treatment subjects were encouraged to increase physical activity and overcome their fear of doing so.
Limitations to this study were acknowledged by the authors. There was no other active or placebo treatment intervention group to help control for provider attention, group interaction, or other nonspecific treatment effects. Interventions pursued and received by the control group were not monitored. Biased sampling might have occurred. Though participants were characteristic of FM subjects chosen in highly cited studies, the individuals who agreed to participate in this study had to be at least open to the possibility that affective factors might be influencing their illness.
All study subjects were women. Though FM appears to be much more prevalent in women when the 1990 ACR criteria are used, which include a tender-point count, eliminating the tender-point count in newly published diagnostic criteria results in a greater number of men with an FM diagnosis.5 Thus, including men with FM in a follow-up ASA intervention study is essential. Further research on effectiveness of the intervention for other chronic pain syndromes that show neurophysiologic similarities to FM would be interesting, e.g., chronic low back pain and irritable bowel syndrome. Schechter et al have reported a case series that suggests that chronic back pain may be treated similarly with success.6
Affective input in the experience of chronic pain is an accepted fact of neurobiology. Finding a fairly quick intervention that provides some lasting relief and capitalizes on this knowledge is a great leap forward for the sufferers of fibromyalgia and the professionals who care for them.
References
1. Wolfe F, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Arthritis Rheum 1990;33:160-172.
2. Sarno JE. The Mindbody Prescription: Healing the Body, Healing the Pain. New York: Warner Books; 1998.
3. Gillis ME, et al. The health effects of at-home written emotional disclosure in fibromyalgia: A randomized trial. Ann Behav Med 2006;32:135-146.
4. Broderick JE, et al. Written emotional expression produces health benefits in fibromyalgia patients. Psychosom Med 2005;67:326-334.
5. Clauw D. Fibromyalgia: Update on mechanisms and management. J Clin Rheumatol 2007;13:102-109.
6. Schechter D, et al. Outcomes of a mind-body treatment program for chronic back pain with no distinct structural pathology a case series of patients diagnosed and treated as tension mysositis syndrome. Altern Ther Health Med 2007;13:26-35.
Women with fibromyalgia participated in a treatment protocol consisting of an educational consultation with a physician, followed by group activities focusing on structured written emotional disclosure and emotional awareness exercises. The treatment group was compared to a wait-list control group of fibromyalgia patients. The affective self-awareness (ASA) intervention significantly improved pain, tenderness, and physical function for at least 6 months in the treatment group compared to the wait-list control group.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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