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资源利用的主要原因。少数患者需要全关节置换术。对传统镇痛药不耐受或无反应者的治疗选择有限。阿片类药物对身体虚弱的老年人有潜在的病态副作用。葡萄糖胺和软骨素，关节内皮质类固醇和透明质酸，关节镜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，患有风湿性疾病（如膝关节OA）的患者经常寻求补充和替代治疗方式，其中针灸是最常见的一种。方法学上的限制阻止了从现有研究中得出关于针灸治疗oa相关膝关节疼痛益处的明确结论。骨膜电针（骨穿刺）是一种比传统中医针灸（TCA）更有效的治疗方法，我们已经取得了非常积极的临床效果，而且它同样安全，易于操作。我们的目的是通过减少社区居住老年人oa相关慢性膝关节疼痛的疼痛严重程度和残疾，来验证我们的临床经验。88名患有持续性膝关节疼痛和骨性关节炎x线证据、无其他风湿病、无膝关节手术史、膝关节以外部位无明显疼痛的老年人将被随机分组，接受每周一次的骨穿刺术或对照骨穿刺术，持续6周。所有结果测量将在治疗前、6周方案完成时和3个月后收集。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来衡量。次要结局包括身体表现、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术是oa相关慢性膝关节疼痛的有效镇痛药，那么未来的研究将包括身体修复以优化身体和社会心理功能，更长的随访时间以确定效果持续时间，以及多种给药方案以优化成本效益比。此外，还将探讨其作用机制，并确定骨穿刺对医疗费用的影响。

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.