Background Chronic non-specific low back pain (CNSLBP) imposes a substantial economic burden. Acupuncture, a key modality in Chinese medicine, is widely used for CNSLBP. However, the therapeutic efficacy of acupuncture may be underestimated due to inadequate induction and evaluation of deqi sensation, a critical component in traditional acupuncture theory. This trial will evaluated the efficacy of 4-week standardized deqi acupuncture in individuals with CNSLBP, with primary and secondary outcomes including Visual Analog Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), 12-Item Short Form Health Survey (SF-12), Pain Catastrophizing Scale (PCS), and shear wave elastography (SWE) measurements of erector spinae (ES) and multifidus (MF). Methods This study is a prospective, two-arm, participant-, assessor-, and statistician-blinded randomized controlled trial. Overall, 100 participants with CNSLBP will be randomly assigned to receive either standardized deqi acupuncture or sham acupuncture over a 4-week intervention period. Follow-up assessments will be conducted at week 8. The primary outcome is the change in VAS scores from baseline. Secondary outcomes include changes in RMDQ, SF-12, PCS, and SWE measurements of ES and MF muscles. All analyses will be conducted based on the intention-to-treat principle. Repeated-measures linear mixed models and ANCOVA will be employed for statistical analysis. Discussion This study is expected to provide robust evidence on the efficacy and safety of standardized Chinese medicine deqi acupuncture for CNSLBP. The findings may offer valuable guidance for clinical practice and inform future research in acupuncture-based pain management. Trial registration International Traditional Medicine Clinical Trial Registry: ITMCTR2025000766. Registered on April 17, 2025.
Chen et al. (Tue,) studied this question.