Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, School of Health Sciences, Faculty of Medicine Dentistry & Health Sciences, The University of Melbourne, VIC, Australia.
BMC Complement Altern Med. 2012 Sep 19;12:161. doi: 10.1186/1472-6882-12-161.
Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain.
METHODS/DESIGN: Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8-12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months.
The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people.
Australian New Zealand Clinical Trials Registry reference: ACTRN12609001001280.
慢性膝关节疼痛是 50 岁以上人群中常见且致残的疾病，膝关节骨关节炎是主要病因。针灸是一种流行的补充和替代医学形式，用于治疗与肌肉骨骼疾病相关的疼痛和功能障碍。这项实用的 Zelen 设计随机对照试验正在研究由医生进行的针和激光针灸治疗 50 岁以上慢性膝关节疼痛患者的疗效和成本效益。
方法/设计：282 名年龄在 50 岁以上的慢性膝关节疼痛患者从澳大利亚墨尔本大都市区和维多利亚州地区招募。最初，参与者同意参加一项纵向自然史研究，但随后被秘密随机分为四组治疗组之一。一组继续按照最初同意的方式（即自然史组），不接受针灸治疗。其他三组是治疗组：i）激光针灸，ii）假激光或，iii）针针灸。针灸治疗采用中西结合的方法，由全科医生进行，共 12 周内进行 8-12 次就诊。目前正在进行随访。主要结局是在 12 周治疗结束时通过 11 点数字评分量表（NRS）测量疼痛和通过 Western Ontario and McMaster（WOMAC）大学骨关节炎指数子量表报告的身体功能。次要结局包括生活质量、全球变化评分以及其他疼痛（其他 NRS 和 WOMAC 子量表）和身体功能（NRS）的测量。其他参数包括一系列社会心理测量，以评估与针灸治疗结果的潜在关系。相对成本效益将根据卫生服务使用和结果数据确定。随访评估还将在 12 个月时进行。
这项研究的结果将有助于确定激光和/或针灸是否对老年人慢性膝关节疼痛的治疗有效且具有成本效益。
澳大利亚新西兰临床试验注册处参考号：ACTRN12609001001280。
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