The effectiveness of Tuina in managing chronic non-specific low back pain: A protocol of a multicenter international randomized controlled trial

Xuan Zhou, Juan Yang, Qing-Yu Ma, Yu Guo, Ke-Jie He, Long-Bin Shen, Qiao Fan, Cheong Kwok Chee Philip, Tay Boon Keng, Tan Ia Choo Celia, Brent A Bauer, Jia-Xu Chen, Xuan Zhou, Juan Yang, Qing-Yu Ma, Yu Guo, Ke-Jie He, Long-Bin Shen, Qiao Fan, Cheong Kwok Chee Philip, Tay Boon Keng, Tan Ia Choo Celia, Brent A Bauer, Jia-Xu Chen

Abstract

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).

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Figure 1
Figure 1
Flow chart of the study. A total of 612 participants will be randomized to the 3 groups. The study period will consist of the baseline, end of 2-month intervention, 3 months post-intervention. FAHJNU = First Affiliated Hospital of Jinan University, MC = Mayo Clinic, SGH = Singapore General Hospital.
Figure 2
Figure 2
Schedule of the study. Each session lasts about 30 minutes, for 6 sessions, over a total of 8 weeks. ODI = Oswestry Disability Index, RCT = randomized controlled trial, ROM = range of motion will be recorded at these points of assessment, SF-36 = 36-item Short-Form Health Survey, VAS = visual analog.

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Source: PubMed

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