Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial.
Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial.
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DOI：
10.1186/1745-6215-9-10
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发表时间：
2008-02-28
期刊：
影响因子：
2.5
通讯作者：
Avins AL
中科院分区：
文献类型：
--
作者：
Cherkin DC;Sherman KJ;Hogeboom CJ;Erro JH;Barlow WE;Deyo RA;Avins AL
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主要原因。因此，客观评估针灸疗效对于就针灸对这种常见病症患者的适当作用做出明智的决定至关重要。这项研究解决了先前评估针灸治疗慢性腰痛的研究中所存在的方法学缺陷。将从西雅图和奥克兰的综合医疗保健服务系统招募总共 640 名参与者（四组各 160 名），年龄在 18 岁至 70 岁之间，腰痛持续至少 3 个月。他们将被随机分配到两种中医针灸疗法（个性化或标准化）中的一种、“对照组”（模拟针灸）或继续常规医疗护理。将在 7 周内提供 10 次治疗。研究参与者和评估参与者并提出个性化治疗建议的“诊断师”针灸师将无法得知实际分配给每个参与者的针灸治疗。提供治疗的“治疗师”针灸师不会被掩盖，但与参与者的口头互动将受到限制。主要结果，即功能障碍和腰痛困扰的标准测量，将在基线时以及 8、26 和 52 周后由不知道治疗分配的电话采访者进行评估。还将衡量一般健康状况、对背部护理的满意度、背部相关残疾的天数以及背痛医疗保健服务的使用和费用。通过随机治疗分配比较结果的主要分析将是根据基线值调整的协方差分析。对于这两项主要结果指标，该试验将有 99% 的功效检测所有四个治疗组之间是否存在最小的临床显着差异，并且对于大多数成对比较有超过 80% 的功效。二次分析将比较每组中改善具有临床意义的量的参与者的比例。该试验的结果将有助于阐明针灸治疗慢性腰痛的价值。临床试验.gov NCT00065585。
Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain. A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount. Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain. Clinical Trials.gov NCT00065585.
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影响因子：
3
作者：
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通讯作者：
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DOI：
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发表时间：
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期刊：
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