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 trialReportar como inadecuado

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, 15:211

First Online: 07 June 2014Received: 07 February 2014Accepted: 07 May 2014DOI: 10.1186-1745-6215-15-211

Cite this article as: Cherkin, D.C., Sherman, K.J., Balderson, B.H. et al. Trials 2014 15: 211. doi:10.1186-1745-6215-15-211


BackgroundThe 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-DesignIn 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.

DiscussionIf 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 Identifier: NCT01467843.

KeywordsBack pain Cognitive-behavioral therapy Mindfulness meditation AbbreviationsAEAdverse event

CAMComplementary and alternative medicine

CATIComputer-assisted telephone interview

CBTCognitive-behavioral therapy

CLBPChronic low back pain

CUACost–utility analysis

DSMBData and Safety Monitoring Board

GHCGroup Health Cooperative

ICD-9International Classification of Diseases Ninth Revision

IPWInverse probability weighting

IRBInstitutional Review Board

MBSRMindfulness-based stress reduction

NCCAMNational Center for Complementary and Alternative Medicine

QALYQuality-adjusted life-year.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-211 contains supplementary material, which is available to authorized users.

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