Efficacy of Acupuncture with PT for Knee Osteo-Arthritis

针灸是一种古老的中国技术，使用细针沿着理论的能量经络刺激穴位，以纠正被认为负责特定疾病状态的不平衡。在美国，针灸常被用来治疗疼痛。1997年美国国立卫生研究院共识会议得出结论，有充分的证据表明在急性牙痛模型和恶心中有效。在慢性疼痛方面，大多数研究规模太小，设计不良，执行不良，或控制不当，不足以充分证明针刺比假针灸，安慰剂，标准药物治疗，甚至不治疗效果更好。膝关节骨关节炎（OA）已被提出作为一个很好的模型来测试针灸在慢性疼痛状况下的疗效，因为它是一种非常常见的、定义明确的、致残的疾病，具有良好的症状和功能状态的结果测量。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）是有效的，这种治疗通常在患者出现功能限制时进行。一项高质量的研究表明，与常规护理对照组相比，针灸治疗膝关节OA有中等程度的益处。因此，一个主要的问题仍然是，除了运动疗法外，针灸是否会在临床上有意义地改善疼痛和功能。由于疼痛可能是提高运动能力的主要限制因素，如果针灸在减轻膝关节OA疼痛方面有任何功效，那么结合EPT项目应该比单独使用EPT更有效。另一个主要的担忧是，针灸的效果可能主要是由非特异性安慰剂效应介导的，而不是由针刺的特异性效应介导的。该建议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代替假穴位。因此，本提案的主要目标是使用一项设计合理的随机盲法临床试验，使用美国风湿病学会（ACR）标准和美国食品和药物管理局（FDA）推荐的结局指标，以确定与安慰剂针灸相比，在标准EPT的基础上增加针灸是否能为症状性膝关节炎患者提供总体临床重要益处。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有反应的患者建立预后和病因模型。如果针灸在临床上有重要的益处，那么这项技术的广泛应用将是合理的。然而，如果结果是阴性的，那么一般应该减少针灸加上EPT。

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.