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

描述(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，但背痛患者的健康和功能状况已经恶化。显然，有必要为这一经常使人虚弱和昂贵的问题确定安全、有效和成本效益高的治疗方案。一些更有希望的慢性背痛治疗方法包括“心身”疗法，它同时解决了疼痛体验的心理和躯体方面的问题。这项随机试验将比较基于正念的压力减轻(MBSR)与常规护理对慢性下腰痛和功能障碍患者的疗效和成本效益。MBSR是一种成熟但研究不足的CAM心身疗法。这项试验还将比较MBSR与传统的心身疗法，认知-行为疗法(CBT)，后者已被发现是一种治疗慢性背痛的适度至中等有效的治疗方法。如果MBSR和/或CBT在这项试验中被证明是有效的，那么这两种不同的心身疗法对疼痛和功能障碍的影响的机制(介体)将被探索。由于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觉，这两种疗法被假设为通过不同的机制运作。共有297名年龄在20岁到之间、有中到重度致残的慢性背痛的成年人将被招募，并按等比例随机分配到MBSR、CBT和照常治疗(通常护理)。MBSR和CBT干预措施将每周向11名参与者提供一次，为期8周。主要结果将是背痛相关的功能限制(罗兰评分)和疼痛困扰(0-10分)。次要结果包括抑郁、焦虑、感觉到的压力、活动的疼痛干扰和睡眠障碍。结果将在随机化后5、10、26和52周进行测量。如果MBSR至少比通常的护理更有效，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，可以更广泛地获得。由于慢性背痛的高患病率和高成本，即使对疼痛和功能影响较小的治疗方法也可以在人群水平上产生巨大的好处。 与公共卫生相关：尽管在过去十年中，国家用于治疗背痛的支出大幅增加，但背痛患者的健康和功能状况却在恶化。这项试验将评估一种安全且相对便宜的“心身”疗法的有效性和成本效益，这种疗法有可能为数百万继续遭受慢性背痛折磨的美国人提供缓解。

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. PUBLIC HEALTH RELEVANCE: Although national expenditures on back pain treatments have increased substantially over the past decade, the health and functional status of persons suffering from back pain has deteriorated. This trial will evaluate the effectiveness, and cost-effectiveness, of a safe and relatively inexpensive "mind-body" therapy that has the potential to provide relief to some of the millions of Americans who continue to suffer from chronic back pain.