Efficacy and Safety of Transcutaneous Acupoint Electrical Stimulation in the Treatment of Cervical Spondylosis: A Multicenter Randomized Open-Labeled Controlled Clinical Study

经皮穴位电刺激治疗颈椎病的疗效和安全性:一项多中心随机开放标签对照临床研究

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Abstract

OBJECTIVE: To evaluate and compare the safety and efficacy of two treatments for cervical spondylosis. One treatment involves the use of electronic wrist-ankle acupuncture, in combination with Tuina, while the other treatment involves using traditional wrist-ankle acupuncture, along with Tuina. The objective was to provide evidence-based support for the treatment of cervical spondylosis using innovative medical device E-WAA combined with Tuina and provide a better treatment option for patients with cervical spondylosis. METHOD: A total of 164 patients with cervical spondylosis from June 2021 to December 2022 were randomly assigned to a control group and an experimental group. The control group received traditional wrist-ankle acupuncture combined with Tuina, while the experimental group received the electronic wrist-ankle acupuncture combined with Tuina. Both groups underwent treatment twice a week for a total of 3 weeks. The primary outcome measure was the improvement rate of visual analog scale score, while the secondary outcome measures were the Neck Disability Index score and cervical range of motion. Safety measures included the recording of adverse reactions during treatment and subjective evaluation of the treatment methods by the patients. Clinical data were analyzed from January to March 2023. RESULT: Both treatment modalities demonstrated improvements in pain and cervical function. There was no significant difference in the VAS improvement rate between the two groups (p = 0.593). However, the electronic wrist-ankle acupuncture combined with Tuina showed an additional benefit in reducing the NDI scores compared to the control group (p = 0.017). During the study, no adverse reaction was reported, and 83.75% of patients considered the electronic wrist-ankle acupuncture device to be safe. CONCLUSION: Both the electronic wrist-ankle acupuncture combined with Tuina and the traditional wrist-ankle acupuncture combined with Tuina showed significant therapeutic effects on cervical spondylosis. In comparison with the traditional wrist-ankle acupuncture, the electronic wrist-ankle acupuncture offers advantages such as noninvasiveness, controllability, and autonomous operation. SIGNIFICANCE: These findings suggest that the electronic wrist-ankle acupuncture can serve as an adjunctive therapeutic approach for patients with cervical spondylosis, providing a more convenient treatment option. TRIAL REGISTRATION: Clinical Trial Registry: ChiCTR2200056394.

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