STUDY PROTOCOL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1664326
This article is part of the Research TopicAdvancements and Optimization of Evidence-Based Approaches in Pain ManagementView all 8 articles
Effectiveness and mechanism of moxibustion in treating chronic non-specific low back pain: study protocol for a multicenter randomized controlled trial
Provisionally accepted
Xuewei Wang1
Caifeng Zhu2*Hongping Pan2Dongsheng Liang3Nana Zhao4Mingming Wang3Bingyuan Zhou1Han Xiang1- 1Anhui University of Chinese Medicine, Hefei, China
- 2The Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China
- 3Chuzhou Hospital of Integrated Traditional Chinese and Western Medicine, Chuzhou, China
- 4Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China
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Introduction: Chronic non-specific low back pain (CNLBP) represents the most commonly encountered subtype of low back pain (LBP) in clinical practice. Moxibustion therapy is commonly utilized in China for managing chronic pain conditions and has demonstrated favorable clinical outcomes. However, high-quality randomized controlled trials remain scarce, and the mechanism of action of moxibustion remains unclear. Consequently, the present research aims to conduct a comprehensive evaluation of the therapeutic efficacy of moxibustion for the management of CNLBP. Additionally, this study will employ modern scientific techniques to conduct a preliminary investigation into the mechanism of action of moxibustion. Methods and analysis: This study will be conducted simultaneously across three tertiary hospitals in China. 150 participants diagnosed with CNLBP will be recruited for this study. Subsequently, these participants will be randomly assigned, following a 1:1 allocation ratio, to undergo either moxibustion or sham moxibustion intervention in accordance with the established research protocol. Treatment will be administered at an identical set of acupoints for all participants: bilateral BL23 (Shenshu), GV3 (Yaoyangguan), and GV8 (Jinsuo). Each session will last 30 minutes, administered three times weekly for 8 weeks, and an 8-week follow-up will be conducted after the completion of the moxibustion intervention. Change in Numerical Rating Scale (NRS) scores from baseline to the 8-week post-intervention assessment constitutes the primary outcome measure. Secondary outcomes will include assessments via the Oswestry Disability Index (ODI), Fear-Avoidance Beliefs Questionnaire (FABQ), 36-Item Short Form Health Survey (SF-36), Global Perceived Effect (GPE), and functional near-infrared spectroscopy (fNIRS). Evaluations for this research will be conducted at baseline, following the intervention (the fourth week), after the completion of intervention (the eighth week), and during the follow-up period (week 16). Discussion: The results obtained from this research are expected to indicate that moxibustion therapy can function as a highly efficacious treatment approach for managing CNLBP. Additionally, this trial will employ fNIRS technology to investigate the activation characteristics of pain-related cortical regions in the brains of CNLBP patients before and after moxibustion treatment. This will contribute to elucidating the underlying mechanisms of moxibustion.
Keywords: Low Back Pain, Moxibustion, sham moxibustion, protocol, functionalnear-infrared spectroscopy, randomized controlled trial
Received: 18 Jul 2025; Accepted: 02 Sep 2025.
Copyright: © 2025 Wang, Zhu, Pan, Liang, Zhao, Wang, Zhou and Xiang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Caifeng Zhu, The Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China
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