Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain

描述（由申请人提供）：慢性背痛仍然是美国最常见和最具挑战性的公共卫生问题之一。尽管在过去十年中，美国用于背痛治疗的资金大幅增加，患有背痛的人的健康和功能状态已经恶化。有一个明确的需要，以确定安全，有效的，具有成本效益的治疗方案，这往往使人衰弱和昂贵的问题。一些更有前途的治疗慢性背痛的方法包括“身心”疗法，解决疼痛体验的心理和躯体方面。这项随机试验将比较正念减压（MBSR）的有效性和成本效益，这是一种成熟但研究不足的CAM身心疗法，与慢性腰痛和功能障碍患者的常规护理。这项试验还将比较MBSR与传统的身心疗法，认知行为疗法（CBT），这已被发现是一个中度到中度有效的治疗慢性背痛。如果MBSR和/或CBT在本试验中证明有效，将探讨这两种不同身心疗法对疼痛和功能障碍的影响机制（介质）。因为CBT旨在改变患者对疼痛的认知和行为反应，而MBSR专注于直接的当下体验，而不是改变对这种体验的想法或感受，这两种疗法被假设为通过不同的机制运作。将招募297名患有中度至重度致残性慢性背痛的20至64岁成年人，并按相同比例随机分配至MBSR、CBT和常规治疗（常规护理）。MBSR和CBT干预措施将提供给11名参与者的小组，每周一次，持续8周。主要结局将是背痛相关的功能限制（罗兰量表）和疼痛困扰（按0-10量表评定）。次要结局包括抑郁、焦虑、感知压力、疼痛干扰活动和睡眠障碍。将在随机化后5、10、26和52周测量结局。如果正念减压疗法至少比常规治疗更有效，这种安全且相对便宜的疗法将为慢性背痛提供一种有吸引力的治疗选择，可以更广泛地使用。由于慢性背痛的高患病率和成本，即使对疼痛和功能有适度影响的治疗也可以在人群水平上产生很大的益处。

DESCRIPTION (provided by applicant): Chronic back pain remains one of the most common and challenging public health problems in the U.S. Although the amount of money spent on back pain treatments has increased substantially over the past decade in the U.S., the health and functional status of persons suffering from back pain has deteriorated. There is a clear need to identify safe, effective, and cost-effective treatment options for this often debilitating and expensive problem. Some of the more promising treatments for chronic back pain include "mind-body" therapies that address both psychological and somatic aspects of the pain experience. This randomized trial will compare the effectiveness and cost-effectiveness of Mindfulness-Based Stress Reduction (MBSR), a well- established but inadequately-studied CAM mind-body therapy, with usual care for persons with chronic low back pain and dysfunction. This trial will also compare MBSR with a conventional mind-body therapy, Cognitive-Behavioral Therapy (CBT), which has been found to be a modestly to moderately effective treatment for chronic back pain. Should MBSR and/or CBT prove effective in this trial, the mechanisms (mediators) of the effects of these two different mind-body therapies on pain and dysfunction will be explored. Because CBT aims to alter patients' cognitive and behavioral responses to pain, whereas MBSR focuses on direct present moment experience and not on changing the thoughts or feelings about such experience, these two therapies are hypothesized to operate by different mechanisms. A total of 297 adults aged 20 through 64 years who have moderately to severely disabling chronic back pain will be recruited and randomized in equal proportions to MBSR, CBT, and treatment as usual (usual care). Both the MBSR and CBT interventions will be provided to groups of 11 participants once a week for 8 weeks. The primary outcomes will be back pain-related functional limitations (Roland scale) and pain bothersomeness (rated on a 0-10 scale). Secondary outcomes include depression, anxiety, perceived stress, pain interference with activities, and sleep disturbance. Outcomes will be measured 5, 10, 26, and 52 weeks after randomization. If MBSR is at least moderately more effective than usual care, this safe and relatively inexpensive therapy would provide an appealing treatment option for chronic back pain that could be made more widely available. Because of the high prevalence and costs of chronic back pain, treatments with even modest impact on pain and function could produce a large benefit on a population level.