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      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

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          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.

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          Most cited references54

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          Mechanisms of mindfulness.

          Recently, the psychological construct mindfulness has received a great deal of attention. The majority of research has focused on clinical studies to evaluate the efficacy of mindfulness-based interventions. This line of research has led to promising data suggesting mindfulness-based interventions are effective for treatment of both psychological and physical symptoms. However, an equally important direction for future research is to investigate questions concerning mechanisms of action underlying mindfulness-based interventions. This theoretical paper proposes a model of mindfulness, in an effort to elucidate potential mechanisms to explain how mindfulness affects positive change. Potential implications and future directions for the empirical study of mechanisms involved in mindfulness are addressed. Copyright (c) 2005 Wiley Periodicals, Inc.
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            Theoretical perspectives on the relation between catastrophizing and pain.

            The tendency to "catastrophize" during painful stimulation contributes to more intense pain experience and increased emotional distress. Catastrophizing has been broadly conceived as an exaggerated negative "mental set" brought to bear during painful experiences. Although findings have been consistent in showing a relation between catastrophizing and pain, research in this area has proceeded in the relative absence of a guiding theoretical framework. This article reviews the literature on the relation between catastrophizing and pain and examines the relative strengths and limitations of different theoretical models that could be advanced to account for the pattern of available findings. The article evaluates the explanatory power of a schema activation model, an appraisal model, an attention model, and a communal coping model of pain perception. It is suggested that catastrophizing might best be viewed from the perspective of hierarchical levels of analysis, where social factors and social goals may play a role in the development and maintenance of catastrophizing, whereas appraisal-related processes may point to the mechanisms that link catastrophizing to pain experience. Directions for future research are suggested.
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              The estimation of a preference-based measure of health from the SF-12.

              The SF-12 is a multidimensional generic measure of health-related quality of life. It has become widely used in clinical trials and routine outcome assessment because of its brevity and psychometric performance, but it cannot be used in economic evaluation in its current form. We sought to derive a preference-based measure of health from the SF-12 for use in economic evaluation and to compare it with the original SF-36 preference-based index. The SF-12 was revised into a 6-dimensional health state classification (SF-6D [SF-12]) based on an item selection process designed to ensure the minimum loss of descriptive information. A sample of 241 states defined by the SF-6D (of 7500) have been valued by a representative sample of 611 members of the UK general population using the standard gamble (SG) technique. Models are estimated of the relationship between the SF-6D (SF-12) and SG values and evaluated in terms of their coefficients, overall fit, and the ability to predict SG values for all health states. The models have produced significant coefficients for levels of the SF-6D (SF-12), which are robust across model specification. The coefficients are similar to those of the SF-36 version and achieve similar levels of fit. There are concerns with some inconsistent estimates and these have been merged to produce the final recommended model. As for the SF-36 model, there is evidence of over prediction of the value of the poorest health states. The SF-12 index provides a useful tool for researchers and policy makers wishing to assess the cost-effectiveness of interventions.
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                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2014
                7 June 2014
                : 15
                : 211
                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
                Article
                1745-6215-15-211
                10.1186/1745-6215-15-211
                4052284
                24906419
                3c66cffc-c294-4b45-a303-51c36c20f0c0
                Copyright © 2014 Cherkin et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 February 2014
                : 7 May 2014
                Categories
                Study Protocol

                Medicine
                back pain,cognitive-behavioral therapy,mindfulness meditation
                Medicine
                back pain, cognitive-behavioral therapy, mindfulness meditation

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