Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital.
Department of Family, Catholic Kwandong University International St. Mary's Hospital, Catholic Kwandong University College of Medicine.
Medicine (Baltimore). 2021 Mar 12;100(10):e24941. doi: 10.1097/MD.0000000000024941.
Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone.
METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome.
This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences.
ClinicalTrials.gov Identifier: NCT03633097.
全膝关节置换术（TKR）是一种手术，由于韩国人口老龄化和人类平均预期寿命的增加，这种手术的实施越来越多。随着 TKR 手术数量的增加，寻求针灸治疗以缓解不良反应、有效止痛、增强 TKR 后康复治疗效果和身体功能的患者数量也在增加。因此，客观评估针灸治疗的安全性和有效性的证据至关重要。本研究旨在验证以下假设：与 TKR 后仅接受常规护理相比，TKR 后同时接受针灸治疗和常规护理治疗对缓解 TKR 症状更有效、更安全且更具成本效益。
方法/设计：这是一项开放标签、平行、评估者盲法随机对照试验，纳入了 50 例 TKR 患者。在筛选患者并获得知情同意后，将患者分为两组（常规护理+针灸组和常规护理组）；然后患者将接受 TKR 手术，并在医院住院 2 周。术后患者将接受共 8 次针灸治疗，持续 2 周，并在干预结束后 3、4 和 12 周进行随访。主要结局采用韩国版 Western Ontario and McMaster Universities Arthritis Index（K-WOMAC）评估，次要结局采用 Numerical Rating Scale（NRS）、跌倒风险和活动范围（ROM）评估。此外，采用每质量调整生命年（QALYs）的成本作为经济评估的主要结果，采用 NRS 每成本作为次要经济结果。
该试验已获得天主教光东大学国际圣玛丽医院伦理委员会的完全伦理批准（IS17ENSS0063）。我们打算将研究结果提交给同行评审期刊和/或会议。
ClinicalTrials.gov 标识符：NCT03633097。
