Osteopuncture for OA-Associated Knee Pain & Disability

描述（由申请人提供）：与骨关节炎（OA）相关的慢性膝关节疼痛是美国老年人身体残疾和医疗保健资源利用的主要原因。少数患者需要全关节置换。对传统止痛药不耐受或无反应的患者治疗选择有限。阿片类药物对体弱的老年人有潜在的病态副作用。氨基葡萄糖和软骨素，关节内皮质类固醇和透明质酸，关节镜下清创和灌洗要么只是适度有效，要么根本没有帮助。由于传统药物治疗经常无效，患有疼痛性风湿性疾病（如膝关节OA）的患者经常寻求补充和替代方式，针灸是最常见的方式之一。方法上的限制阻止了从现有研究中得出关于针灸治疗OA相关膝关节疼痛的明确结论。骨膜电针（骨穿刺）是一种比传统中国针灸（TCA）更有效的方式，我们已经取得了非常积极的临床效果，并且它同样安全，易于执行。我们的目的是验证我们的临床经验，这项随机对照试点研究，减少疼痛的严重程度和残疾的社区居住的老年人与OA相关的慢性膝关节疼痛。88例持续性膝关节疼痛和OA X线证据、无其他风湿性疾病、无膝关节手术史和膝关节以外部位无明显疼痛的老年人将随机接受骨穿刺或对照骨穿刺，每周一次，持续6周。将在治疗前、6周方案完成时和3个月后收集所有结局指标。主要结果是疼痛和残疾，用西安大略和麦克马斯特大学骨关节炎指数测量。次要结果包括身体表现、心理社会功能（情绪、自我效能、应对、恐惧、自评健康）、睡眠和食欲。如果这项初步研究表明，骨穿刺是OA相关慢性膝关节疼痛的有效止痛剂，未来的研究将设计包括身体修复，以优化身体和心理社会功能，更长的随访期，以确定效果的持续时间，以及多剂量方案，以优化成本效益比。此外，还将探索作用机制，并确定骨穿刺对医疗保健成本的影响。

DESCRIPTION(provided by applicant): Chronic knee pain associated with osteoarthritis (OA) is a leading cause of physical disability and health care resource utilization for older Americans. A minority of patients requires total joint replacement. Those intolerant or unresponsive to traditional analgesics have limited therapeutic options. Opioids have potentially morbid side effects in frail older adults. Glucosamine and chondroitin, intra-articular corticosteroids and hyaluronic acid, and arthroscopic debridement and lavage have either been only modestly effective or not helpful at all. Because of the frequent inefficacy of traditional medications, patients with painful rheumatologic disorders such as knee OA not infrequently seek complementary and alternative modalities, with acupuncture being one of the most common. Methodologic constraints prevent definitive conclusions regarding the benefits of acupuncture for OA-associated knee pain being drawn from existing studies. Periosteal electroacupuncture (osteopuncture) is a more potent modality than traditional Chinese acupuncture (TCA), with which we have had very positive clinical results, and it is just as safe and easy to perform. We aim to validate our clinical experience with this randomized controlled pilot study by reducing pain severity and disability in community-dwelling older adults with OA-associated chronic knee pain. 88 older adults with persistent knee pain and x-ray evidence of OA, no other rheumatologic disorders, no history of knee surgery, and no prominent pain in sites other than the knee(s) will be randomized to receive either osteopuncture or control osteopuncture once a week for 6 weeks. All outcome measures will be collected pre-treatment, at the completion of the 6-week protocol, and 3 months later. The primary outcomes are pain and disability, measured with the Western Ontario and McMaster Universities Osteoarthritis Index. Secondary outcomes include physical performance, psychosocial function (mood, self-efficacy, coping, fear, self-rated health), sleep and appetite. If this preliminary study suggests that osteopuncture is an effective analgesic for OA-associated chronic knee pain, future studies will be designed that include physical reconditioning to optimize physical and psychosocial function, longer follow-up periods to determine duration of effects, and multiple dosing protocols to optimize the cost-benefit ratio. In addition, mechanisms of action will be explored, and the impact of osteopuncture on health care costs determined.