Department of Rehabilitation Medicine of Korean Medicine, Pusan National University Korean Medicine Hospital, Yangsan, 50612, Republic of Korea.
Department of Korean Medicine, School of Korean Medicine, Pusan National University, Yangsan, 50612, Republic of Korea.
Trials. 2019 Apr 15;20(1):216. doi: 10.1186/s13063-019-3302-y.
Low back pain (LBP) is common, with a lifetime prevalence of 80%, and as such it places substantial social and economic burden on individuals and society. Chuna manual therapy (CMT) combines aspects of physiology, biodynamics of spine and joint motion, and basic theory of movement dynamics. This study aimed to test the comparative effectiveness and safety of CMT for non-acute LBP.
A three-arm, multicenter, pragmatic, randomized controlled pilot trial was conducted from 28 March 2016 to 19 September 2016, at four medical institutions. A total of 60 patients were randomly allocated to the CMT group (n = 20), usual care (UC) group (n = 20), or combined treatment (CMT + UC) group (n = 20), and received the relevant treatments for 6 weeks. The primary outcome was a numeric rating scale (NRS) representation of LBP intensity, while secondary outcomes included NRS of leg pain, Oswestry disability index (ODI), Patient Global Impression of Change (PGIC), the EuroQol-5 dimensions (EQ-5D), lumbar range of motion, and safety.
A total of 60 patients were included in the intention-to-treat analysis and 55 patients (CMT, 18; UC, 18; CMT + UC, 19) were included in the per-protocol analysis (drop-out rate 5.3%). Over the treatment period there were significant differences in the NRS score for LBP (CMT mean - 3.28 (95% CI - 4.08, - 2.47); UC - 1.95 (- 2.82, - 1.08); CMT + UC - 1.75 (- 2.70, - 0.80), P < 0.01) and the ODI scores in each group (CMT - 12.29 (- 16.86, - 7.72); UC - 10.34 (- 14.63, - 6.06); CMT + UC - 9.27 (- 14.28, - 4.26), P < 0.01). The changes in other secondary outcomes did not significantly differ among the three groups. Sixteen minor-to-moderate safety concerns were reported.
Our results suggest that CMT has comparative efficacy for non-acute LBP and is generally safe. As this was a preliminary study, a well-powered (over 192 participants) two-arm (CMT versus UC) verification trial will be performed to assess the generalizability of these results.
Clinical Research Information Service (CRIS), KCT0001850 . Registered on 12 March 2016.
腰痛（LBP）很常见，终生患病率为 80%，因此它给个人和社会带来了巨大的社会和经济负担。脊医手法治疗（CMT）结合了生理学、脊柱和关节运动的生物动力学以及运动动力学的基本理论。本研究旨在测试非急性 LBP 的 CMT 的比较效果和安全性。
这是一项 3 臂、多中心、实用、随机对照的先导试验，于 2016 年 3 月 28 日至 2016 年 9 月 19 日在 4 家医疗机构进行。共有 60 名患者被随机分配到 CMT 组（n=20）、常规护理（UC）组（n=20）或联合治疗（CMT+UC）组（n=20），并接受了为期 6 周的相关治疗。主要结局是腰痛强度的数字评分量表（NRS）表示，次要结局包括腿部疼痛的 NRS、Oswestry 残疾指数（ODI）、患者总体印象变化（PGIC）、EuroQol-5 维度（EQ-5D）、腰椎活动度和安全性。
共有 60 名患者被纳入意向治疗分析，55 名患者（CMT，18 名；UC，18 名；CMT+UC，19 名）被纳入方案分析（失访率为 5.3%）。在治疗期间，LBP 的 NRS 评分（CMT 平均 -3.28（95%CI-4.08，-2.47）；UC-1.95（-2.82，-1.08）；CMT+UC-1.75（-2.70，-0.80），P<0.01）和每组 ODI 评分（CMT-12.29（-16.86，-7.72）；UC-10.34（-14.63，-6.06）；CMT+UC-9.27（-14.28，-4.26），P<0.01）有显著差异。三组间其他次要结局的变化无显著差异。报告了 16 例轻度至中度安全问题。
我们的结果表明，CMT 对非急性 LBP 具有比较疗效，且总体安全。由于这是一项初步研究，将进行一项（超过 192 名参与者）双盲（CMT 与 UC）验证试验，以评估这些结果的普遍性。
临床研究信息服务（CRIS），KCT0001850。于 2016 年 3 月 12 日注册。
