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

CAM 与传统身心疗法治疗慢性背痛的比较

• 批准号: 8528480
• 负责人: DANIEL C. CHERKIN
• 金额: $ 73.27万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8528480
• 关键词: Address; Adult; American; Anxiety; Awareness; Back; Back Pain; Behavioral; Belief; Breathing Exercises; Caring; Characteristics; Chronic; Chronic low back pain; Clinical; Cognition; Cognitive; Cognitive Therapy; Complementary and alternative medicine; Coping Behavior; Disabled Persons; Effectiveness; Expenditure; Feeling; Functional disorder; Guidelines; Health; Health Status; High Prevalence; Intervention; Knowledge; Life; Measures; Mediating; Mediator of activation protein; Medical; Medical Care Costs; Meditation; Mental Depression; Mind-Body Intervention; Outcome; Pain; Pain Research; Pain interference; Participant; Patients; Persons; Policies; Population; Public Health; Randomized; Recruitment Activity; Relaxation; Relaxation Therapy; Research; Rest; Safety; Self Efficacy; Signal Transduction; Sleep disturbances; Stress; Subgroup; Therapeutic; Thinking; Training; Treatment Cost; Yoga; aged; base; chronic back pain; comparative effectiveness; compare effectiveness; coping; cost; cost effective; cost effectiveness; effective therapy; experience; functional status; improved; mindfulness; mindfulness-based stress reduction; primary outcome; progressive relaxation therapy; psychologic; randomized trial; response; secondary outcome; systematic review; treatment as usual; treatment effect

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.

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。尽管过去十年美国用于背痛治疗的资金大幅增加，但健康和功能状况患有背痛的人的情况已经恶化。显然需要为这个经常使人衰弱且昂贵的问题找到安全、有效和具有成本效益的治疗方案。一些更有前景的慢性背痛治疗方法包括“身心”疗法，可解决疼痛体验的心理和躯体方面的问题。这项随机试验将比较正念减压 (MBSR)（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的有效性和成本效益。该试验还将 MBSR 与传统的身心疗法、认知行为疗法 (CBT) 进行比较，后者被发现是治疗慢性背痛的一种中等至中等有效的治疗方法。如果 MBSR 和/或 CBT 在本试验中被证明有效，那么这两种不同的身心疗法对疼痛和功能障碍的影响机制（中介）将得到探索。由于 CBT 旨在改变患者对疼痛的认知和行为反应，而 MBSR 侧重于直接的当下体验，而不是改变对此类体验的想法或感受，因此假设这两种疗法通过不同的机制起作用。将招募总共 297 名年龄在 20 岁至 64 岁之间、患有中度至重度慢性背痛的成年人，并按相同比例随机分配接受 MBSR、CBT 和照常治疗（常规护理）。 MBSR 和 CBT 干预措施将每周向 11 名参与者提供一次，持续 8 周。主要结果是背痛相关的功能限制（罗兰量表）和疼痛困扰（按 0-10 分制评分）。次要结果包括抑郁、焦虑、感知压力、疼痛干扰活动和睡眠障碍。结果将在随机分组后 5、10、26 和 52 周进行测量。如果MBSR至少比常规护理更有效，那么这种安全且相对便宜的疗法将为慢性背痛提供有吸引力的治疗选择，并且可以更广泛地应用。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不大的治疗也可能对人群产生巨大的益处。