| Objective:This study aims to verify the clinical efficacy and safety of CX-DZ-II intelligent electroacupuncture instrument,to promote the clinical application of the intelligent electroacupuncture instrument,and to enrich the intelligent evidence-based diagnosis and treatment equipment of acupuncture and moxibustion.Methods:The patients with neck pain who met the inclusion criteria were randomly divided into two groups: the observation group(CX-DZ-II intelligent electroacupuncture apparatus)and the control group(SDZ-II electroacupuncture apparatus).According to the treatment plan,the patients in the two groups completed 5consecutive treatments once a day in the first week,and complete the remaining 3treatments in the 2nd week,1 time every 2 days.A total of one course of treatment.To evaluate curative effect by observing VAS score,SF-MPQ score,NPQ score and scores of treatment scores of cervical spondylosis at different observation points.The safety and performance of instruments were evaluated during the treatment.At the same time,the adverse events and device defects were observed and recorded.Results:1.Baseline Analysis:The compared baseline of the demographic data(gender,age,height,weight),vital signswere and severity’s indicators(duration,VAS score,SF-MPQ score,NPQ score and scores of treatment scores of cervical spondylosis)of all the patients are consistent with good comparability when they entered their groups respectively(P > 0.05).2.Efficacy Evaluation:(1)The Visual Analogue Score of neck pain at 5th time and at the end of treatment are both significantly lower than that before treatment(P<0.001),withoutstatistics difference existing between the two groups(P > 0.05).(2)After treatment,the scores of SF-MPQ,NPQ and the score of cervical spondylopathy are significantly different from those before treatment(P < 0.001).There is no significant difference in NPQ and SF-MPQ between the two groups(P > 0.05).There is no significant difference in the scores of conscious symptom and daily life in the score of cervical spondylopathy(P > 0.05).The clinical examination scores and total scores of the score of cervical spondylopathy are significantly different(P<0.05).3.Effectiveness Comparison:At the end of treatment,the clinical effective rate was 97.2% in the observation group and 94.9% in the control group.There is no significant difference in clinical efficacy between the two groups(P>0.05).4.Safety Assessment:There occurred 1 case of halo needle in the observation group.There is no significant difference of the incidence of adverse events between the two groups(P>0.05).5.Performance Assessment:Comparing the sensitivity of the CX-DZ-II intelligent electroacupuncture treatment instrument and the SDZ-II electroacupuncture treatment,the difference is statistically significant(P<0.001).Conclusion:1.CX-DZ-II intelligent electroacupuncture therapy instrument and SDZ-II electroacupuncture therapy instrument are both effective in treating neck pain of cervical spondylosis,and the efficacy basically the same.2.CX-DZ-II intelligent electroacupuncture therapy instrument and SDZ-II electroacupuncture therapy instrument are both safe and effective in the treatment of neck pain.3.The sensitivity of CX-DZ-II intelligent electroacupuncture therapy instrument is better than that of SDZ-II electroacupuncture instrument. |