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已发表论文
推拿结合药油治疗非特异性下背痛的疗效评价：一项随机临床试验
Authors Wang S, Yuan M, Guo G , Nguyen TTT, Zheng Y, Yin Z, Wang Y, Yao F, Wang G, Xu H
Received 28 July 2025
Accepted for publication 7 October 2025
Published 3 November 2025 Volume 2025:18 Pages 5781—5796
DOI https://doi.org/10.2147/JPR.S554329
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Houman Danesh
Siyu Wang,1,* Man Yuan,2,3,* Guangxin Guo,1,4,* Trinh Thach Thi Nguyen,2,3 Yannan Zheng,2,3 Zhiyang Yin,4 Yongwei Wang,2,3 Fei Yao,1,4 Guimao Wang,1 Hongxi Xu2,3
1Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 3Engineering Research Center of Shanghai Colleges for T.C.M. New Drug Discovery, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 4School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Hongxi Xu, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Pudong District, Shanghai, 201203, People’s Republic of China, Tel/Fax +86 021-51323089, Email hxxu@shutcm.edu.cn Guimao Wang, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, No. 274 Zhijiang Middle Road, Jing’an District, Shanghai, 200071, People’s Republic of China, Tel/Fax +86 137 6462 8380, Email SHUTCMwgm@163.com
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.
Keywords: non-specific low back pain, Tuina, medicated oil, back pain, clinical trial
1Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 3Engineering Research Center of Shanghai Colleges for T.C.M. New Drug Discovery, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 4School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Hongxi Xu, School of Pharmacy, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Pudong District, Shanghai, 201203, People’s Republic of China, Tel/Fax +86 021-51323089, Email hxxu@shutcm.edu.cn Guimao Wang, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, No. 274 Zhijiang Middle Road, Jing’an District, Shanghai, 200071, People’s Republic of China, Tel/Fax +86 137 6462 8380, Email SHUTCMwgm@163.com
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.
Keywords: non-specific low back pain, Tuina, medicated oil, back pain, clinical trial