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Tuina therapy for chronic nonspecific low back pain: a randomized clinical trial protocol
Siwei Zhou1, Changzheng Jiang1, Qiangwen Xie2,3
1Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
Background:
Chronic Non-Specific Low Back Pain (CNLBP) is a prevalent musculoskeletal condition. Tuina therapy and non-steroidal anti-inflammatory drugs (NSAIDs) are two commonly used treatments for CNLBP, both of which have demonstrated some clinical efficacy. However, the effectiveness, safety, and potential opioid-sparing effects of Tuina, a classic complementary and alternative therapy, have yet to be rigorously validated through clinical research.
Objective:
This study aims to conduct a randomized controlled superiority trial with an open-label design, blinded assessment, and parallel groups to evaluate the effectiveness, safety, and complementary role of Tuina in the treatment of CNLBP.
Study Design And Methods:
This is a single-center, randomized controlled, assessor-blind clinical trial. A total of 80 participants aged 18-60 years meeting the diagnostic criteria for CNLBP will be recruited and randomly assigned to either the experimental group (Tuina combined with Loxoprofen Sodium patches) or the control group (Loxoprofen Sodium patches). The Tuina intervention will be administered three times weekly for four consecutive weeks; Loxoprofen Sodium patches will be used as needed. The primary outcome measure is the Visual Analogue Scale (VAS) for pain after 4 weeks of treatment. Secondary outcomes include the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), Beck Depression Inventory-Second Edition (BDI-II), Beck Anxiety Inventory (BAI), Surface Electromyography (sEMG) and musculoskeletal ultrasound (MSK US) parameters, medication usage, and 12-week follow-up data. Statistical analysis will follow the intention-to-treat (ITT) principle, using SPSS 26.0 for between-group comparisons and repeated measures analysis.
Discussion:
Through a rigorous randomized controlled design incorporating both physiological and morphological objective indicators, this study aims to provide high-level evidence regarding the analgesic efficacy, safety, and potential for drug dose reduction of Tuina in treating CNLBP. It also seeks to offer clinical evidence and practical references for the application of Tuina in the rehabilitation of musculoskeletal disorders.
Clinical Trial Registration:
https://itmctr.ccebtcm.org.cn/mgt/project/user/user-project-view/4621255a-332d-4ba4-b09b-e9412ba06d0b, Identifier (ITMCTR2026000745).