| ObjectiveTo discuss the effectiveness and safety of the Intelligent Electronic Acupuncture Apparatus (IEAA) machine, broaden the thoughts of treating KOA with acupuncture.Methods60patients were divided randomly into the two groups based on the randomized, controlled and double-blinded principle, with28patients in the treating group, in which the IEAA machine designed by Dongguan Nanxing Electronic Co. Ltd was applied, and32patients in the control group, in which the the normal Hwato SDZ-II type Electric Acupuncture Machine was applied. The selection of acupoints in both groups were Liangqiu(ST34), Xuehai (SP10), Dubi(ST35), Neixiyan(EX-LE5), Yinlingquan(SP9), Yanglingquan(GB34).(of the affected knee).Needling methods:The patient was required to take a position with knee bending90°.Other acupoints were needled vertically in the depth of0.8-1.2cun. Neither manipulation nor slight needling sensation was required. Then both machine was adjusted as follows:Type of wave:density variable wave, the frequency of the sparse wave, lasting for5seconds, was one fifth of that of the dense wave, lasting for10seconds. Frequency:38Hz±10%. Treating time:30minutes. Period:once a day, five times a week, and2weeks in total, lasted for10times totally. The WOMAC questionnaire, the VAS questionnaire, the TCM syndrome assessment and the total therapeutic assessment were to be evaluated in the period of before treatment, the fifth treatment, the tenth treatment,28days after treatment ended. Adverse events or severe adverse events were to be recorded at any time during the treatment. Statistical method:Data of this research was calculated and analyzed by the software SPSS19.0. Measurement data was demonstrated in the means of x±s, while enumeration data was demonstrated in the means of percentage. The paired t-test was applied in the comparison within groups, while the t-test was applied in the comparison between groups. The rank-sum test was applied when there was a heterogeneity of variance. The chi-square test was applied in the comparison of total effective rate between groups.OutcomesIn total,60patients were recruited in this clinical research, among which four cases were dropped and one case were eliminated.55patients finished this clinical research, among which there were26patients in the treating group and29in the control group.Comparison of the baseline before treatment:There is of no statistical significance between the demographic data and the past patient history. The WOMAC questionnaire:the means of the treating group and the control group are1202.71±546.98and1040.44±408.92respectively, with the Z value is1.001and the P value is0.269, which indicates that there is of no statistical significance. The VAS questionnaire:the means of the treating group and the control group are7.43±1.46and6.39±1.55respectively, with the t value is1.040and the P value is0.301, which indicates that there is of no statistical significance. The TCM syndrome assessment:The means of the treating group and the control group are33.86±10.28and29.44±8.53respectively, with the Z value is-0.095and the P value is0.924, which indicates that there is of no statistical significance between two groups. The baseline was aligned.The fifth treatment:the WOMAC questionnaire:the means of the treating group and the control group are777.04±388.02and759.31±376.273respectively, with the Z value is0.454and the P value is0.986, which indicates that there is of no statistical significance between two groups. Comparison within groups: compared with before treatment, the t value of the WOMAC questionnaire is6.315in the treating group and8.930in the control group. The P values are0.000, indicating that there is of great statistical significance.The VAS questionnaire:the means of the treating group and the control group are4.52±1.49and4.67±1.29, respectively, with the t value is1.530and the P value is0.129, which indicates that there is of no statistical significance. Comparison within groups:compared with before treatment, the t value of the VAS questionnaire is3.064in the treating group and8.136in the control group. The P values are0.000, indicating that there is of great statistical significance.The TCM syndrome assessment:the means of the treating group and the control group are23.93±9.31and22.28±7.89respectively, with the Z value is-0.853and the P value is0.394, which indicates that there is of no statistical significance between two groups. Comparison within groups: compared with before treatment, the t value of the TCM syndrome assessment is8.325in the treating group and5.706in the control group. The P values are0.000, indicating that there is of great statistical significance.The tenth treatment:the WOMAC questionnaire:the means of the treating group and the control group are446.04±230.14and629.24±316.127respectively, with the Z value is1.630and the P value is0.010, which indicates that there is of statistical significance between two groups. Comparison within groups:compared with before treatment, the t value of the WOMAC questionnaire is7.457in the treating group and10.782in the control group. The P values are0.000, indicating that there is of great statistical significance.The VAS questionnaire:the means of the treating group and the control group are2.33±1.22and3.38±1.43, respectively, with the t value is-3.673and the P value smaller than0.01, which indicates that there is of great statistical significance. Comparison within groups:compared with before treatment, the t value of the VAS questionnaire is15.787in the treating group and10.418in the control group. The P values are0.000, indicating that there is of great statistical significance.The TCM syndrome assessment:the means of the treating group and the control group are17.46±6.54and18.48±7.74respectively, with the Z value is2.188and the P value is0.029, which indicates that there is of statistical significance between two groups. Comparison within groups:compared with before treatment, the t value of the TCM syndrome assessment is9.089in the treating group and6.532in the control group. The P values are0.000, indicating that there is of great statistical significance.28days after the treatment ended:the WOMAC questionnaire:the means of the treating group and the control group are500.46±273.607and723.90±359.98respectively, with the Z value is1.400and the P value is0.010, which indicates that there is of statistical significance between two groups. Comparison within groups:compared with before treatment, the t value of the WOMAC questionnaire is7.664in the treating group and7.580in the control group. The P values are0.000, indicating that there is of great statistical significance.The VAS questionnaire:the means of the treating group and the control group are2.79±1.18and3.94±1.56, respectively, with the t value is-3.037and the P value smaller than0.01, which indicates that there is of great statistical significance. Comparison within groups:compared with before treatment, the t value of the VAS questionnaire is14.221in the treating group and8.588in the control group. The P values are0.000, indicating that there is of great statistical significance.The TCM syndrome assessment:the means of the treating group and the control group are18.69±6.88and19.93±8.22respectively, with the Z value is-1.996and the P value is0.049, which indicates that there is of statistical significance between two groups. Comparison within groups:compared with before treatment, the t value of the TCM syndrome assessment is9.777in the treating group and6.492in the control group. The P values are0.000, indicating that there is of great statistical significance.Difference value and comparison between groups:the WOMAC difference value: the means of the treating group and the control group are674.73±448.88and313.07±222.42respectively, with the Zvalue is1.753and the Pvalue is0.004, which indicates that there is of great statistical significance between two groups.The chi-square value is3.804and the P value is0.029. The chi-square value of the change for the four assessment time is248.521and the P value is smaller than0.01, indicating that there is of statistical significance between two groups, the VAS value:the means of the treating group and the control group are4.57±1.64and2.53±1.59respectively, with the Z value is3.648and the P value is smaller than0.01, which indicates that there is of great statistical significance between two groups. The chi-square value is6.61and the P value is0.017. The chi-square value of the change for the four assessment time is335.551and the P value is smaller than0.01, indicating that there is of statistical significance between two groups. The TCM syndrome difference value:the means of the treating group and the control group are15.15±7.90and9.10±7.55respectively, with the Z value is-1.753and the P value is0.080, which indicates that there is of great statistical significance between two groups. The chi-square value of the change for the four assessment time is245.120and the P value is smaller than0.01, indicating that there is of statistical significance between two groups.During the research, The total effective rate of the treating group is96.15%while that of the control group is82.76%. The chi-square value is5.471and the P value is0.035, indicating that there is of statistical significance between two groups. The marked effective rate of the treating group is76.92%while that of the control group is37.93%. The chi-square value is8.474and the P value is0.004, indicating that there is of great statistical ignif icance between two groups.During the research, no undesirable event takes place and no severe side-effect is detected.ConclusionThis research demonstrate conclusion that the general therapeutic effects of treating KOA with both electronic machines are effective. However, the therapeutic effect of the NX-DJ01IEAA machine is superior to that with the SDZ-II electronic acupuncture, during which no undesirable event and no severe side-effect have taken place. According to this facts, it is concluded that the NX-DJ01IEAA machine is both safe and effective. |
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