Formula-Pattern Research Center, School of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong Province, China.
Division of General Internal Medicine, Mayo Clinic, Rochester, MN.
Medicine (Baltimore). 2022 Feb 18;101(7):e28883. doi: 10.1097/MD.0000000000028883.
BACKGROUND: Chronic non-specific low back pain (CNLBP) is a common complaint about medical care and carries a heavy social burden. The efficacy of Tuina (TN) or physiotherapy (PT) for CNLBP has been evaluated in previous systematic reviews. However, there is no high-quality evidence to support the efficacy of Tuina. Therefore, this study aims to conduct a large-scale, multicenter, high-quality clinical trial to provide evidence for Tuina to treat CNLBP. METHODS: This is a multicenter, assessor-, and analyst-blinded, randomized controlled trial with 3 parallel arms: TN, PT, and TN combined with PT (Tuina combined with physiotherapy) group. Six hundred twelve eligible CNLBP patients will be randomly assigned to the groups in a 1:1:1 ratio in 3 centers. The TN intervention includes 9-step routine techniques, while the PT intervention includes a physiotherapy treatment plan based on a patient's symptoms. The interventions for both groups will last for 30 minutes and will be carried out for 6 sessions in 8 weeks. The primary outcome will be the visual analog scale pain score. And the secondary outcomes will include the Oswestry Disability Index, spinal range of motion, 36-item short-form health survey. Safety evaluation will be recorded during the whole study. All data in this randomized controlled trial will be analyzed by SAS 9.4. DISCUSSION: The results of this trial will provide evidence to evaluate the efficacy of Tuina's value as a treatment for CNLBP. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2000040288, November 27, 2020).
背景:慢性非特异性下腰痛(CNLBP)是医疗保健中常见的抱怨,且具有沉重的社会负担。推拿(TN)或物理疗法(PT)治疗 CNLBP 的疗效已在前瞻性系统评价中进行了评估。然而,目前尚无高质量证据支持推拿的疗效。因此,本研究旨在开展一项大规模、多中心、高质量的临床试验,为推拿治疗 CNLBP 提供证据。
方法:这是一项多中心、评估者和分析者盲法、随机对照试验,设有 3 个平行组:TN 组、PT 组和 TN 联合 PT(推拿联合物理疗法)组。将在 3 个中心以 1:1:1 的比例将 612 名符合条件的 CNLBP 患者随机分配到各组。TN 干预包括 9 步常规技术,而 PT 干预包括根据患者症状制定的物理治疗计划。两组的干预均持续 30 分钟,在 8 周内进行 6 次治疗。主要结局将是视觉模拟评分疼痛评分。次要结局包括 Oswestry 残疾指数、脊柱活动度、36 项简明健康调查。整个研究期间将记录安全性评估。本随机对照试验中的所有数据将由 SAS 9.4 进行分析。
讨论:该试验的结果将提供证据来评估推拿治疗 CNLBP 的疗效。
试验注册:中国临床试验注册中心(ChiCTR2000040288,2020 年 11 月 27 日)。
Medicine (Baltimore). 2025-1-17