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: 6330810
• 负责人: JOHN T FARRAR
• 金额: $ 58.91万
• 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/6330810
• 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，它使用细针刺激了理论上的能量子午线，以纠正被认为负责特定疾病状态的失衡。 在美国，针灸通常用于治疗疼痛状况。 1997年的NIH共识会议得出的结论是，在急性牙齿疼痛模型和恶心中有足够的疗效证据。 在慢性疼痛中，大多数研究太小，设计较差，执行不当或受到不当控制，无法充分证明针刺的起作用要比假针刺，安慰剂，标准药物治疗甚至没有治疗更好。膝盖的骨关节炎（OA）已被认为是在慢性疼痛状态下测试针灸功效的好模型，因为它是一种极为普遍，定义良好且破坏症状和功能状态的良好结果指标。 有临床试验证据证明对对乙酰氨基酚和NSAID的标准治疗方法有效，并进行物理疗法（EPT），通常在患者产生功能限制时添加。 一项对膝盖OA针灸的高质量研究在与通常的护理对照组的无盲界比较中表现出适度的好处。 因此，一个主要问题仍然是关于针灸，除了运动疗法外是否将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，因此，如果针灸在减轻膝盖OA的疼痛方面具有任何功效，那么与EPT程序的组合应比单独使用EPT更有效。 另一个主要问题是，针灸的作用可能主要是由非特异性安慰剂效应而不是针刺的特定作用介导的。 该提案的另一个重要组成部分是我们使用经过验证的盲目安慰剂针而不是假针刺点。因此，该提案的主要目的是使用美国风湿病学院（ACR）标准和食品药物管理学院（FDA）建议采用的成果指标，使用适当设计的随机盲临床试验，以确定与症状性膝盖OA相比，在标准EPT中添加针灸是否为临床上重要的临床重要受益。 作为次要目标，我们将使用临床试验数据为最有可能对针灸做出反应的患者开发预后和病因。 如果发现针灸具有临床上重要的好处，则该技术的更广泛应用是合理的。 但是，如果结果为负，则通常应限制在EPT中添加针灸。