EVALUATING THE EFFICACY OF ACUPUNCTURE FOR BACK PAIN

评估针灸治疗背痛的疗效

• 批准号: 6153495
• 负责人: DANIEL C. CHERKIN
• 金额: $ 48.89万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2001-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6153495
• 关键词: acupuncture /acupressure; alternative medicine; backache; clinical research; diagnosis; health science research analysis /evaluation; health services research tag; human subject; human therapy evaluation

A recent NIH Consensus Development Conference on Acupuncture noted that many studies have evaluated acupuncture, but "provide equivocal results because of design, sample size, and other factors." The report concluded that studies overcoming these methodologic challenges would be necessary if valid conclusions were to be reached concerning the efficacy of acupuncture. The goals of the proposed study are to develop and evaluate methods for improving the scientific quality of randomized trials evaluating the efficacy of acupuncture, and to use this information to design and pilot test a randomized clinical trial of the efficacy of acupuncture for persistent low back pain. We will first develop the methods necessary for a valid and meaningful evaluation of acupuncture. We will document the range of diagnoses and treatments for low back pain and the extent to which treatment choice depends on diagnosis. This will involve review of key acupuncture texts, analyses of acupuncture practice data and a survey of a random sample of licensed acupuncturists. We will also conduct a study of the extent of variation in acupuncturists' assessments, diagnoses, and treatments for the same patient. We will use this information to identify an appropriate standardized acupuncture treatment protocol for low back pain that is consistent with common practice and considered credible to practitioners. We will identify and evaluate appropriate comparison treatments, including a credible non-needle treatment and a needle- control treatment, that are indistinguishable from real acupuncture by acupuncture-naive subjects. We will also identify methods for " blinding" therapists in controlled trials, or at least minimizing potential bias from being unblinded. The findings from these methodological investigations will then be used to design and implement a pilot randomized trial that addresses the following questions: 1) Is acupuncture effective for persistent low back pain?, 2) Is acupuncture more effective when needles are inserted in acupuncture points believed to be effective than when they are inserted in sites believed to be ineffective?, 3) Is acupuncture more effective than standard medical care? 4) Is individualized acupuncture more effective than standardized acupuncture? We will randomize a total of 100 subjects to standardized acupuncture, individualized acupuncture, non-specific needle acupuncture, non-needle (placebo) acupuncture or usual medical care. We will measure each treatment's impact on symptoms, function, satisfaction and utilization/costs of care after 4 weeks, 10 weeks, and 6 months. The pilot study will test the feasibility of conducting a full-scale trial and permit estimation of sample size, requirements.

NIH最近的针灸共识发展会议指出， 许多研究已经评估了针灸，但“提供了模棱两可的结果 由于设计，样本量和其他因素。”报告 结论是，克服这些方法论挑战的研究将 如果要得出有效的结论，就必须 针灸的功效。 拟议的研究的目标是发展 并评估改善随机科学质量的方法 评估针灸功效的试验，并使用此功能 设计和试点测试的信息 针灸对持续的下背痛的功效。 我们将首先 开发有效且有意义评估所需的方法 针刺。 我们将记录 腰痛以及治疗选择依赖的程度 诊断。 这将涉及对关键针灸文本的审查，分析 针灸练习数据和对许可的随机样本的调查 针灸师。我们还将对变异程度进行研究 针灸师的评估，诊断和治疗 病人。 我们将使用此信息来确定适当的 下背痛的标准化针灸治疗方案 与共同的实践一致，并认为可信 从业者。 我们将确定并评估适当的比较 治疗，包括可靠的非针对治疗和针 - 控制处理，与实际针灸无法区分 针灸对象。 我们还将确定“ 在对照试验中盲目的治疗师，或至少最小化 潜在的偏见是不盲的。 这些发现 然后将使用方法研究来设计和实施 试点随机试验解决以下问题：1）是 针灸对持续的腰痛有效吗？，2）针灸是针灸吗 当针刺插入针灸点时，更有效 比将它们插入被认为是有效的地方 无效？，3）针灸比标准医疗更有效 关心？ 4）个性化针灸比标准化更有效 针刺？ 我们将对总共100名受试者随机进行标准化 针灸，个性化针灸，非特异性针头 针灸，非针刺（安慰剂）针灸或通常的医疗服务。 我们将衡量每种治疗对症状，功能， 4周，10周后的满意和利用/护理费用 6个月。 试点研究将测试进行一次的可行性 全面试验和允许估算样本量，要求。