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The effectiveness of Tuina in managing chronic non-specific low back pain: A protocol of a multicenter international
Xuan Zhou1, Juan Yang2, Qing-Yu Ma1
1Formula-Pattern Research Center, School of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong Province, China.
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).
