Abstract
PURPOSE: Non-specific low back pain (NSLBP) causes functional impairments and reduced quality of life. Evidence for non-pharmacological approaches, such as Tuina and Flying Eagle Wood Lok Medicated Oil (TNO), remains limited. This study compares the efficacy of TNO and Tuina with water (TNW). PATIENTS AND METHODS: This single-center, open-label, evaluator-blinded randomized controlled trial (June 2023 - June 2025) was conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine with 100 participants aged 20-59 years, diagnosed with NSLBP based on the North American Spine Society criteria. The Ethics Committee (2023SHL-KY-96-01) approves the study, and assessors are blinded to group assignments for objective evaluations. All participants provided informed consent and completed the study. The trial group received TNO treatment thrice weekly for 4 weeks, with 20-minute follow-up sessions, compared to TNW. The primary outcome was the Visual Analog Scale (VAS) score, with secondary outcomes (JOA scores, Infrared Thermography, muscle tension, and tenderness scores). Adverse reactions were recorded for safety assessment. RESULTS: This trial recruited 100 patients (mean [SD] age, 35.0 [5.2] years; 57 [57%] female) who were randomized into two groups. One hundred percent of patients completed all outcome measurements. The mean difference in VAS scores from baseline at week 8 for the TNO group was -4.48 (95% CI, -4.89 to -4.07). At week 8, the difference in JOA scores for the TNO groups was 10.8 (95% CI, 10.12 to 11.48; P <0.001). The effectiveness remained at the follow-up. LC-MS analysis identified 621 compounds (Negative: 258, Positive: 363). CONCLUSION: This study found that TNO was more effective than Tuina alone, with improved pain, muscle tension, tenderness, and thermal imaging at 8 weeks. Thus, this combination should be considered for the treatment of non-specific low back pain. The short follow-up period (8 weeks), the single-center design, and the absence of a placebo oil group are significant limitations that may restrict generalizability. TRIAL REGISTRATION CHINESE CLINICAL TRIAL REGISTRY: : ChiCTR2300076144.