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Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (6): 1385-1394.DOI: 10.19852/j.cnki.jtcm.2025.06.016

• Original Articles • Previous Articles     Next Articles

Efficacy and safety of Shi’s cervical manipulation versus diclofenac for patients with acute and subacute neck pain: a multicenter clinical randomized trial

ZHANG Mingcai1, LIN Xun5, DU Guoqing1, LIU Congying2, YUAN Weian1, LI Wei3, YANG Jiayu4, CHEN Bo1, YU Xiaoyue3, XIONG Yizhe1, JIANG Enyu4, GAO Ningyang1, JIANG Sumin3, XU Zhenqiu1, WANG Xiang1, ZHAN Hongsheng1(), WU Yufeng6()   

  1. 1 Shi's Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    2 Science and Technology Center of Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    3 Traumatology & Orthopedics Department of Jing'an District Central Hospital of Shanghai, Shanghai 200040, China
    4 Traumatology & Orthopedics Department of Xiangshan Hospital of Traditional Chinese Medicine, Shanghai 200001, China
    5 College of International Education of Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    6 Traumatology & Orthopedics Department of Zhongshan Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine, Zhongshan 528401, China
  • Received:2024-02-27 Accepted:2025-01-18 Online:2025-12-15 Published:2025-11-24
  • Contact: Prof. WU Yufeng, Traumatology & Orthopedics Department of Zhongshan Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine, Zhongshan 528401, China. wyfdoc301@163.com, Telephone: +86-21-20256519; +86-760-88803661;
    Prof. ZHAN Hongsheng, Shi’s Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. zhanhongsheng@shutcm.edu.cn
  • About author:ZHANG Mingcai and LIN Xun are co-first authors and contributed equally to this work
  • Supported by:
    Biomechanical Mechanism of Tendon Off-position and Joint Subluxation and Manual Treatment for Adolescent Neck Pain(82374467);Research on the Mechanism of Manipulation to Regulate Internalizing Integrin and its Downstream Focal Adhesion Kinase/Ras Homolog Gene Family Member A/Rho-associated Coiled-coil Containing Protein Kinase 1 Signaling Pathway to Repair Chronic Skeletal Muscle Injury(82374481);Mechanism of Huaizhen Nourishing the Liver Capsule to Maintain the Balance of Knee Joint from the Coupling and Interaction of Skeletal Muscle-subchondral Bone Dynamics Rresponse(81704103)

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Abstract:

OBJECTIVE: To confirm the effectiveness and safety of Shi's manipulation in treating acute and subacute neck pain patients.

METHODS: This multicenter, positive controlled, randomized clinical trial has trial and control groups. There were 240 patients randomly assigned to the trial group and the control group, and both groups received their respective intervention treatment methods for a period of 12 weeks. The time windows for clinical data collection were before treatment, immediately after treatment, 3-d 1, 2, 4, 8, and 12 -week after treatment, and follow-up was conducted at 26 and 52-week after treatment. The observed indicators used include primary outcome index and secondary outcome index, with the primary outcome index being the assessment of neck pain severity, which is evaluated by patients using Numerical Rating Scale (NRS). Secondary secondary outcome index include, (a) cervical dysfunction index, measured by patients using the Neck Disability Index (NDI) for self-assessment; (b) Cervical activity measurement, measured through the cervical range of motion measurement program on Android mobile system; (c) Satisfaction treatment assessment, determined by the patient's self-evaluation; (d) Safety index, recorded the incidence of adverse reactions and adverse event.

Results: The results showed that these efficacy indices were improved in different degrees in both groups. At immediate after intervention, there was significant difference in NRS, NDI, Cervical Range of Motion (ROM) between the two groups (P < 0.01), the trial group was superior to the control group. At 3-d after intervention, there was significant difference in NRS, NDI, ROM between the two groups (P < 0.01). At 1-week and 2-week after intervention, there was significant difference in NDI and ROM between the two groups (P < 0.01). At 4-week and 6-week after intervention, there was significant difference in NDI, ROM between the two groups (P < 0.05). At 8-week after intervention, there was significant difference in NDI, lateral-bending and axial-rotation ROM between the two groups (P < 0.05). At 12-week after intervention, there was significant difference in NDI between the two groups (P < 0.01). At 26-week and 52-week after intervention, there was significant difference in NDI, NRS between the two groups (P < 0.01). In addition, the adverse reaction of trial group is significantly lower than that of control group (P < 0.05). The satisfaction of patients in the trial group was better than that in the control group (P < 0.01).

CONCLUSION: Our findings suggest that Shi's manipulation can be a good complementary treatment option in patients with acute and subacute neck pain.

Key words: neck pain, treatment outcome, safety, Shi’s cervical manipulation, diclofenac sodium sustained-release capsules

Cite this article

ZHANG Mingcai, LIN Xun, DU Guoqing, LIU Congying, YUAN Weian, LI Wei, YANG Jiayu, CHEN Bo, YU Xiaoyue, XIONG Yizhe, JIANG Enyu, GAO Ningyang, JIANG Sumin, XU Zhenqiu, WANG Xiang, ZHAN Hongsheng, WU Yufeng. Efficacy and safety of Shi’s cervical manipulation versus diclofenac for patients with acute and subacute neck pain: a multicenter clinical randomized trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(6): 1385-1394.