Efficacy of Acupuncture with PT for Knee Osteo-Arthritis

针灸是一种古老的中国技术，使用细针刺激沿着理论经络的能量点，以纠正被认为是负责特定疾病状态的不平衡。 在美国，针灸通常用于治疗疼痛。 1997年NIH共识会议得出结论，有足够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，设计不佳，执行不佳，或控制不当，无法充分证明针刺比假针灸，安慰剂，标准药物治疗，甚至没有治疗效果更好。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条件下的疗效，因为它是一个非常常见的，定义明确的，和禁用的条件与良好的结果措施的症状和功能状态。 有临床试验证据表明，对乙酰氨基酚和NSAID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。 一项关于针灸治疗膝关节OA的高质量研究在与常规护理对照组的非盲比较中显示出中度获益。 因此，一个主要的问题仍然是针灸，除了运动疗法，是否会提供一个临床上有意义的改善疼痛和功能。 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疼痛方面有任何疗效，那么与EPT计划相结合应该比单独使用EPT更有效。 另一个主要的问题是，针灸的效果可能主要是由非特异性安慰剂效应介导的，而不是针的放置的特定效应。 这项提议的另一个重要组成部分是我们使用一种经过验证的盲法安慰剂针，而不是假穴位。因此，本提案的主要目标是使用设计合理的随机盲法临床试验，使用美国流变学学会（ACR）标准和美国食品药品监督管理局（FDA）推荐的结局指标，以确定与安慰剂针灸相比，在标准EPT中添加针灸是否为症状性膝关节OA患者提供了总体临床重要获益。 作为第二个目标，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。 如果发现针灸的临床重要益处，则该技术的更广泛应用将是合理的。 然而，如果结果是负面的，那么除了针灸EPT一般应该减少。

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.