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Open Access Highly Accessed Study protocol

Comparison of complementary and alternative medicine with conventional mind–body therapies for chronic back pain: protocol for the Mind–body Approaches to Pain (MAP) randomized controlled trial

Daniel C Cherkin12*, Karen J Sherman13, Benjamin H Balderson1, Judith A Turner4, Andrea J Cook15, Brenda Stoelb1, Patricia M Herman6, Richard A Deyo7 and Rene J Hawkes1

Author Affiliations

1 Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA

2 Departments of Family Medicine and Health Services, University of Washington, Box 357660, Seattle, WA 98195, USA

3 Department of Epidemiology, University of Washington, Box 357236, Seattle, WA 98195, USA

4 Departments of Psychiatry and Behavioral Sciences and Rehabilitation Medicine, University of Washington, Box 356560, Seattle, WA 98195, USA

5 Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, USA

6 RAND Corporation, 1776 Main Street, Santa Monica, CA, USA

7 Departments of Family Medicine, Internal Medicine, Public Health and Preventive Medicine, and the Center for Research in Occupational and Environmental Toxicology, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA

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Trials 2014, 15:211  doi:10.1186/1745-6215-15-211

Published: 7 June 2014

Abstract

Background

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes.

Methods/Design

In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks.

Discussion

If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.

Trial registration

Clinicaltrials.gov Identifier: NCT01467843.

Keywords:
Back pain; Cognitive-behavioral therapy; Mindfulness meditation