Efficacy of Acupuncture with PT for Knee Osteo-Arthritis

针刺配合PT治疗膝骨关节炎的疗效

• 批准号: 6731059
• 负责人: JOHN T FARRAR
• 金额: $ 73.59万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-15 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6731059
• 关键词: acupuncture /acupressure; alternative medicine; arthritis therapy; chronic pain; clinical trials; combination therapy; functional ability; human subject; human therapy evaluation; knee; osteoarthritis; patient oriented research; physical therapy

Acupuncture is an ancient Chinese technique of using a fine needle to stimulate points along theoretical meridians of energy to correct imbalances thought to be responsible for specific disease states. In the United States, acupuncture is often used for the treatment of painful conditions. The 1997 NIH Consensus Conference concluded that there was adequate evidence of efficacy in an acute dental pain model and in nausea. In chronic pain, most studies were too small, poorly designed, poorly executed, or improperly controlled to adequately demonstrate that needle acupuncture worked better than sham acupuncture, placebo, standard medical therapy, or even no treatment. Osteoarthritis (OA) of the knee has been proposed as a good model to test the efficacy of acupuncture in a chronic pain condition because it is an extremely common, well defined, and disabling condition with well established outcome measures for symptoms and functional status. There is clinical trial evidence of efficacy for the standard treatments of acetaminophen and NSAIDs, and exercise physical therapy (EPT), which is usually added when the patient develops functional limitations. One high quality study of acupuncture for knee OA, demonstrated moderate benefit in an unblinded comparison to a usual care control group. As such, a major question remains about whether acupuncture, used in addition to exercise therapy, will provide a clinically meaningful improvement in pain and function. Since pain can be the primary limiting factor in improved exercise capacity, if acupuncture has any efficacy in reducing the pain of knee OA, then the combination with an EPT program should be substantially more effective than EPT alone. Another major concern is that the effect of the acupuncture may be predominantly mediated by non- specific placebo effects rather than the specific effects of the placement of a needle. Another important component of this proposal is our use of a validated blinded placebo needle instead of sham acupuncture points. Therefore, the primary goal of this proposal is to use a properly designed randomized blinded clinical trial, using American College of Rheumatology (ACR) criteria and Food and Drug Administration (FDA) recommended outcome measures, to determine whether the addition of acupuncture to standard EPT provides an overall clinically important benefit to patients with symptomatic knee OA compared to placebo acupuncture. As a secondary goal, we will use the clinical trial data to develop prognostic and etiologic models for the patients that are most likely to respond to acupuncture. If a clinically important benefit for acupuncture is found, a broader application of this technique would be justified. However, if the results are negative, then the addition of acupuncture to EPT should be generally curtailed.

针灸是一种古老的中国技术，使用细针刺激理论上的能量经络上的穴位，以纠正被认为导致特定疾病状态的不平衡。 在美国，针灸经常用于治疗疼痛。 1997 年 NIH 共识会议得出的结论是，有足够的证据表明其在急性牙痛模型和恶心中的功效。 在慢性疼痛方面，大多数研究规模太小、设计不当、执行不当或控制不当，无法充分证明针灸比假针灸、安慰剂、标准药物治疗甚至不治疗效果更好。膝骨关节炎 (OA) 已被认为是测试针灸治疗慢性疼痛疗效的良好模型，因为它是一种极其常见、定义明确且致残的疾病，具有完善的症状和功能状态结果测量方法。 有临床试验证据表明，对乙酰氨基酚和非甾体抗炎药的标准治疗以及运动物理治疗 (EPT) 有效，通常在患者出现功能限制时添加运动物理治疗。 一项关于针灸治疗膝骨关节炎的高质量研究在非盲法比较中证明了针灸与常规护理对照组有一定的疗效。 因此，一个主要问题仍然是，除了运动疗法之外，使用针灸是否能够对疼痛和功能产生临床上有意义的改善。 由于疼痛可能是提高运动能力的主要限制因素，如果针灸对减轻膝关节 OA 疼痛有任何功效，那么与 EPT 计划相结合应该比单独 EPT 更有效。 另一个主要问题是，针灸的效果可能主要是由非特异性安慰剂效应介导的，而不是由针放置的特定效应介导的。 该提案的另一个重要组成部分是我们使用经过验证的盲法安慰剂针而不是假针灸点。因此，本提案的主要目标是采用正确设计的随机盲法临床试验，采用美国风湿病学会 (ACR) 标准和美国食品药品监督管理局 (FDA) 推荐的结果指标，以确定是否将针灸添加到标准 EPT 中与安慰剂针灸相比，针灸为有症状的膝骨关节炎患者提供了总体临床上重要的益处。 作为次要目标，我们将利用临床试验数据为最有可能对针灸产生反应的患者开发预后和病因模型。 如果发现针灸在临床上具有重要的益处，那么该技术的更广泛应用将是合理的。 然而，如果结果是否定的，那么一般应减少在 EPT 中添加针灸。