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.
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.
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.
The results of this trial will provide evidence to evaluate the efficacy of Tuina's value as a treatment for CNLBP.
Chinese Clinical Trial Registry (ChiCTR2000040288, November 27, 2020).
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。
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。
该试验的结果将提供证据来评估推拿治疗 CNLBP 的疗效。
中国临床试验注册中心（ChiCTR2000040288，2020 年 11 月 27 日）。
