Efficacy of Acupuncture for Chronic Low Back Pain

描述（由申请人提供）： 一项5臂多中心随机对照试验，旨在阐明针灸可以在多大程度上减少慢性腰痛对患者功能和症状的影响。审查指出，这一领域的研究质量很差，并敦促进行科学严谨的研究。 最近的高质量试验表明，针灸是一种有前途的治疗背痛的方法。 这项研究直接解决了困扰以前的研究方法的缺点。 具体目标是确定，慢性腰痛，如果：1）针灸比安慰剂针灸更有效，2）个体化针灸比标准化针灸更有效，3）当针插入被认为对慢性腰痛有效的穴位时，针灸比当针插入被认为对慢性腰痛无效的穴位时更有效，4）针灸比单纯的药物治疗更有效。 将从西雅图、奥克兰和檀香山的组模型HMO中招募共1100例腰痛持续至少3个月的受试者（每组220例）。 他们将被随机分配到两种形式的中医针灸（个性化或标准化），两个“对照”组（模拟针灸或针刺无效点）之一，或继续常规医疗护理。将在7周内提供10次治疗。 主要结局，功能障碍和腰痛的困扰，将在基线时以及3周、8周、26周和52周后由对治疗不知情的电话访问者进行测量。 将使用意向治疗背景下的协方差分析来分析数据。 由于慢性背痛是一个主要的公共卫生问题，也是患者寻求针灸治疗的首要原因，因此明确、明确的评估对于做出明智的决定至关重要，即针灸是否应该作为背痛的传统护理的一部分，还是应该纳入保险。 这项研究的结果将提供最明确的证据，迄今为止的价值针灸作为一种治疗慢性腰痛。

DESCRIPTION (provided by applicant): A 5-arm multi-site randomized controlled trial is proposed to clarify the extent to which acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. Specific aims are to determine, for chronic low back pain, if: 1) acupuncture is more effective than placebo acupuncture, 2) individualized acupuncture is more effective than standardized acupuncture, 3) acupuncture is more effective when needles are inserted in acupuncture points believed effective for chronic low back pain than when needles are inserted in points considered ineffective for chronic low back pain, 4) acupuncture is more effective than usual medical care alone. A total of 1100 subjects (220 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, Oakland, and Honolulu. They will be randomized to one of two forms of Traditional Chinese Medical acupuncture needling (individualized or standardized), one of two "control" groups (simulated acupuncture or needling of ineffective points), or to continued usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 3, 8, 26 and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.