Efficacy of Acupuncture with PT for Knee Osteo-Arthritis

针灸是一种古老的中国技术，它使用细针沿着理论上的能量经络刺激穴位，以纠正被认为导致特定疾病状态的失衡。在美国，针灸经常被用来治疗疼痛。1997年NIH共识会议的结论是，有足够的证据表明，在急性牙痛模型和恶心方面是有效的。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。膝骨性关节炎(OA)是一种非常常见、定义明确、致残性的疾病，其症状和功能状态的预后指标已被确定，因此已被建议作为测试针灸在慢性疼痛条件下疗效的良好模型。有临床试验证据表明，扑热息痛和非甾体抗炎药的标准治疗以及运动物理疗法(EPT)的有效性，运动物理疗法通常在患者出现功能障碍时添加。一项高质量的针灸治疗膝骨性关节炎的研究表明，与常规护理对照组相比，非盲法治疗有适度的益处。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。由于疼痛可能是运动能力提高的主要限制因素，如果针灸在减轻膝骨性关节炎疼痛方面有任何效果，那么结合EPT计划应该比单独EPT有效得多。另一个主要的担忧是，针灸的效果可能主要是由非特定的安慰剂效应调节的，而不是针头放置的特定效应。这项建议的另一个重要组成部分是我们使用了有效的盲用安慰剂针，而不是假的针灸穴位。因此，这项建议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)标准和食品和药物管理局(FDA)推荐的结果指标，以确定与安慰剂针刺相比，在标准EPT的基础上加用针灸是否能为症状性膝骨性关节炎患者提供总体的临床重要益处。作为第二个目标，我们将使用临床试验数据为最有可能对针灸有反应的患者开发预后和病因模型。如果发现了针灸在临床上的重要益处，这项技术的更广泛应用将是合理的。然而，如果结果是阴性的，那么在EPT的基础上应该减少针灸治疗。

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.