School of Traditional Chinese Medicine, Jinan University, Guangzhou, China.
Department of Acupuncture, First Affiliated Hospital of Jinan University, Guangzhou, China.
Complement Ther Med. 2024 Nov;86:103098. doi: 10.1016/j.ctim.2024.103098. Epub 2024 Oct 10.
To rigorously evaluate the short-term and long-term effectiveness of Tuina (TN), alone and in combination with physiotherapy (PT), for Chronic nonspecific low back pain (CNLBP) through a comprehensive, high-quality clinical trial.
This randomized, single-blind trial was conducted from September 2020 to July 2023, involving 204 CNLBP patients from the First Affiliated Hospital of Jinan University. Participants underwent a baseline assessment, 6 treatment sessions over 8 weeks, a post-treatment evaluation in the 9th week, and a 20-week follow-up. Participants were randomly assigned to TN, PT, or a combination of TN and PT (TP) groups. Each treatment involved 6 sessions with a minimum 7-day interval, each lasting 30 minutes. Primary outcome was the change in Visual Analog Scale (VAS) for pain. Secondary outcomes included the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), Range of Motion (ROM) of the spine, Traditional Chinese Medicine Syndrome Scale (TCMSS), and adverse events (AE).
Among the 204 participants, 67.16 % were female, and 88.73 % completed the 20-week follow-up. All groups showed significant reductions in VAS scores post-treatment and at follow-up. Secondary outcomes improved significantly, with notable decreases in ODI and TCMSS scores. Pairwise comparisons within groups indicated statistical significance, particularly in ODI scores, with clinical relevance. No significant differences were found between the groups. ROM and SF-36 showed statistical but not clinical significance. Only one AE (0.49 %) was reported, with no severe incidents.
All treatment groups, including TN, TP, and PT, demonstrated significant reductions in VAS scores for CNLBP patients, with effects lasting up to 20 weeks. While TN and TP showed substantial improvements in secondary outcomes, particularly in ODI scores, no significant differences were found between the groups. These findings suggest that all treatments can be effective for managing CNLBP, supporting clinical practitioners in selecting appropriate interventions for patients, especially for those unable to engage in active exercises, utilizing passive movements like TN to enhance health outcomes.
通过全面、高质量的临床试验,严格评估推拿(TN)单独及联合物理疗法(PT)治疗慢性非特异性下腰痛(CNLBP)的短期和长期疗效。
本随机、单盲试验于 2020 年 9 月至 2023 年 7 月进行,纳入来自暨南大学第一附属医院的 204 例 CNLBP 患者。参与者接受基线评估、8 周内 6 次治疗、第 9 周治疗后评估和 20 周随访。参与者被随机分配到 TN、PT 或 TN 和 PT 联合(TP)组。每种治疗方法均涉及 6 次治疗,每次治疗之间至少间隔 7 天,每次治疗持续 30 分钟。主要结局是疼痛视觉模拟量表(VAS)的变化。次要结局包括 Oswestry 残疾指数(ODI)、36 项简明健康调查问卷(SF-36)、脊柱活动度(ROM)、中医证候量表(TCMSS)和不良事件(AE)。
在 204 名参与者中,88.73%完成了 20 周随访,女性占 67.16%。所有组在治疗后和随访时 VAS 评分均显著降低。次要结局均显著改善,ODI 和 TCMSS 评分显著降低。组内两两比较显示有统计学意义,尤其是 ODI 评分,有临床意义。组间无显著差异。ROM 和 SF-36 显示有统计学意义但无临床意义。仅报告了 1 例不良事件(0.49%),无严重事件。
包括 TN、TP 和 PT 在内的所有治疗组均使 CNLBP 患者的 VAS 评分显著降低,疗效持续至 20 周。TN 和 TP 在次要结局,尤其是 ODI 评分方面有显著改善,但组间无显著差异。这些发现表明,所有治疗方法均可有效治疗 CNLBP,支持临床医生为患者选择适当的干预措施,尤其是对那些无法进行主动锻炼的患者,利用被动运动如 TN 来提高健康结局。