| ObjectiveTo evaluate clinical efficacy and safety of NX-DF01intelligent electronic acupuncture system for the treatment of cervical spondylosis neck pain so as to enrich the clinical treatment method for patients with neck pain of cervical spondylosis.MethodsUsing randomized controlled methods to recruite62patients with neck pain of cervical spondylosis who are included in the standard of recruition as the subjects, and randomly divide them into treatment group (32cases) and control group(30cases). Acupoints of two groups are the bilateral Jianzhongshu(SI15)、Bailao (EX-HX15)、Xinshe、Zhongzhu (SJ3). After the needle bringing about the desired sensation, NX-DJ01intelligent electronic acupuncture system would be linked to the treatment group’s patients, SDZ-II electric acupuncture apparatus would be linked to the control group’patients with dilatational wave and the frequency is38Hz±10%; The treatment course includes30minutes per treatment,5times treatment a week,2weeks for one course,10times treatment totally. To use Northwick Park neck pain scale (NPQ) and visual analogue scale (VAS), TCM syndrome classification score as evaluation indicators before treatment, at the end of the fifth treatment, all the treatments and1month after all treatments respectively, and record adverse reactions/adverse events during the process of research at any time. Using statistical software PASW18.0to do statistical analysis of the data collected. The count data were expressed in percentage(%) and chi-square test is used for count data comparison between two groups. Measurement data were expressed in with mean±standard deviation (x±s). Independent sample t test is used for measurement data comparison between two groups and the comparison within each group would use paired t test. If the data is non normal distribution or variance not neat, rank sum test would be used.Results1The baseline comparisonThere were no statistically significant differences in age, duration, history of professional, Chinese/western medicine treatment history, NPQ score, visual analogue scale (VAS) score and TCM syndrome classification score of treatment group and control group (P>0.05). The two groups are comparable with the equal baseline.2Comparison within each group(1)Treatment group①The differences of NPQ score between the fifth treatment and the treatment before, the end of treatment and the fifth treatment were statistically significant (P=0.000), but there was no statistical significant difference between1months after the treatment and the end of treatment (P=0.409).②The differences of VAS score between the fifth treatment and the treatment before, the end of treatment and the fifth treatment,1months after the treatment and the end of treatment were statistically significant (P=0.000,0.000,0.010).③The differences of TCM syndrome score the fifth treatment and the treatment before, the end of treatment and the fifth treatment were statistically significant (P=0.000), but there was no statistical significant difference between1months after the treatment and the end of treatment (P=0.813).(2)Control group①The differences of NPQ score between the fifth treatment and the treatment before, the end of treatment and the fifth treatment were statistically significant (P=0.000,0.004), but there was no statistical significant difference between1months after the treatment and the end of treatment (P=0.307).②The differences of VAS score between the fifth treatment and the treatment before, the end of treatment and the fifth treatment,1months after the treatment and the end of treatment were statistically significant.000,0.000,0.001).'The differences of TCM syndrome score between the fifth treatment and the treatment before was statistically significant (P=0.000), but there was no statistical significant difference between the end of treatment and the fifth treatment,1months after the treatment and the end of treatment (P=0.161,0.537).3Comparison between two groups(1)①he NPQ scores of treatment group at the fifth treatment, the end of treatment,1months after the treatment were20.65±7.73,13.32±7.26,13.61±6.29, and the NPQ scores of control group were23.33±8.72,19.20±7.06,20.32±8.82. Comparing the scores of two groups, the differences at the fifth treatment was not statistically significant (P=0.212), but at the end of the end of treatment and1months after treatment was statistically significant (P=0.002,0.001).②The VAS scores of treatment group at the fifth treatment, the end of treatment,1months after the treatment were3.30±1.18,2.16±1.12,2.76±1.17, and control group were4.62±1.18,3.41±1.33,4.25±1.47. Comparing the scores of two groups, the differences were statistically significant (P=0.000).③he TCM syndrome scores of treatment group at the fifth treatment, the end of treatment,1months after the treatment were9.87±5.93,7.55±4.08,7.42±3.10, and control group were11.38±5.56,10.14±6.11,10.55±6.43. Comparing the scores of two groups, there was no significant difference at the fifth treatment and the end of treatment (P=0.262,0.155), but at1months after the end of treatment was statistically significant (P=0.041).(2) The differences of NPQ score, VAS score difference after treatment and before treatment were statistically significant (P=0.011,0.013), while the difference of TCM syndrome score difference was not statistically significant (P=0.122).4Comparison of effective rateThe clinical effective rates of treatment group at the end of all the treatments and1month after treatment were90.3%,90.6%respectively, while the clinical effective rates of the control group were82.7%,75.8%. Differences of effective rate between the treatment group and control group were not statistically significant (P>0.05).5Safety evaluationTreatment group had1case of adverse events, which had nothing to do with intelligent electronic acupuncture system. The control group had three adverse events.2cases had nothing to do with electric acupuncture apparatus, and the other case was associated with electric acupuncture apparatus. All adverse events above did not influence the research process.Conclusion1.The curative effect of NX-DJO1intelligent electronic acupuncture system and SDZ-IIt for the treatment of cervical spondylosis neck pain are basically the same, but the NX-DJO1intelligent electronic acupuncture system can greatly reduce NPQ score and VAS score.2. NX-DJO1intelligent electronic acupuncture system is safe and effective for the treatment of cervical spondylosis neck pain, which is worthy of clinical generalization. |
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