Efficacy of Acupuncture for Chronic Low Back Pain

描述(由申请人提供)： 一项5臂多点随机对照试验被提出，以阐明针刺可以在多大程度上减轻慢性下腰痛对患者功能和症状的影响。审查注意到这一领域的研究质量很差，并敦促进行科学严谨的研究。最近更高质量的试验表明，针灸是一种很有前途的背痛治疗方法。这项研究直接解决了困扰先前研究的方法缺陷。具体目的是确定对于慢性下腰痛，是否：1)针灸比安慰剂针灸更有效，2)个性化针灸比标准化针灸更有效，3)针灸在被认为对慢性下腰痛有效的穴位比在被认为对慢性下腰痛无效的穴位更有效，4)针灸比单纯常规医疗更有效。将从西雅图、奥克兰和火奴鲁鲁的团体模型医疗保健组织招募1100名腰痛持续至少3个月的受试者(每只手臂220名)。他们将被随机分为两种形式的中医针灸疗法(个体化或标准化)、两个“对照”组(模拟针灸或针刺无效穴位)之一，或继续常规医疗护理。将在7周内提供10种治疗方法。主要结果，下腰痛的功能障碍和烦扰，将在基线时以及3、8、26和52周后由戴着面具接受治疗的电话采访者进行测量。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重大的公共卫生问题，也是患者寻求针灸治疗的首要原因，因此，对于是否应该将针灸纳入传统的背痛治疗或保险覆盖范围，明确、毫不含糊的评估对于做出明智的决定至关重要。这项研究的结果将为针灸作为治疗慢性下腰痛的价值提供迄今为止最明确的证据。

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.