| ObjectiveTo evaluate the clinical effectiveness and safety of the CAJ moxibustion therapeutic instrument in treatment of knee osteoarthritis(KOA).Methods70 cases of KOA were randomly divided into a treating group in which the CAJ moxibustion therapeutic instrument was used and a control group in which the DAJ multi-function moxbustion instrument was used, based on the randomized, controlled and double-blinded principle. There were 35 patients in each group. Xiyan(ST 35), Yangliangquan(GB 34), Yinlingquan (ST9), Neiguan (PE6) were selected in two groups. The treating temperature was 45℃ and it varied on how the patients felt. All the patient received 10 treatment sessions,40 minutes treatment every other day. Pain and joint function were assessed using a visual analogue scale(VAS)、WOMAC index before the treatment、at the 5th treatment、at the 10th treatment and 1 month of the end. 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 SPSS20.0. Measurement data was demonstrated in the means of x ±s, while enumeration data was demonstrated in the means of percentage. The paired t-test or t’Test was applied in the comparison within groups, while the variance analysis and pairwise comparison was applied in the comparison between groups. Repetitive measurement deviation analysis was applied in comparion of the measurement data at all time points observed. The rank-sum test was applied when there was a heterogeneity of variance. The chi-square test and fisher’s exact test were applied in the comparison of total effective rate between groups. Test size:α=0.05, two-sided test.Results1 In total,70 patients were recruited in this clinical research and 35 ones in each group. Seven cases were dropped and two cases were eliminated.61 patients finished this clinical research, among which there were 32 patients in the treating group and 29 in the control group.2 Comparison of the baseline prior treatment:There is of no statistical significance between the age, ethnicity, profession, disease course, medical history, allergic history, comorbidities, daily drugs, demographic data and vital signs.The VAS questionnaire:the means of the treating group and the control group were 5.61±1.19 and 6.10±1.29, with the P value is 0.301, which indicates that there is of no statistical significance. The WOMAC questionnaire:the means of the treating group and the control group were 588.72 ±295.35 and 799.62±473.72, with the P value is 0.082, which indicates that there was of no statistical significance.The baseline was aligned and it’s Comparable between groups.3 The changes of evaluation indicators3.1 The changes of VAS score questionnaireBefore treating, the means of treating group and the control group were 5.61±1.19 and 6.10±1.29. At the fifth treatment the means of treating group and the control group were 3.87±1.27 and 4.24±1.63. At the end of the treatment, the means of treating group and the control group were 2.17±1.21 and 2.71±1.59. After 1month of the end, the means of treating group and the control group were 1.96±1.02 and 2.72±1.93.Intra-group comparision:Compared with before treatment,there was of no statistical significance, the value of P is 0.000.Comparison among groups:There was of no statistical significance, the value of P is 0.129 before treating.There was of no statistical significance between the treating group and the control group at the 5th treatment,at the end of the treatment and 1 month after the treatment,the P value were 0.325, There was of no statistical significance between the treating group and the control group at the 5th treatment, at the end of the treatment and 1 month after the treatment, the P value were 0.879,0.227,0.180.3.2 The reductive ratio of VAS At the 5th treatment,the treating group was 30.89±16.04 and the control group was 30.15+21.26.At the end of the treatment,the treating group was61.97土18.19 and the control group was 55.89±20.71.After 1 month of the end,the treating group was 65.29+16.60 and the control group was 55-69+27.11,and3.3 The changes of WOMAC questionnaireBefore treating the means of treating group and the control group were 588.72±295.35 and 799.62±473.72. After the fifth treatment the means of treating group and the control group were 346.26±228.83 and 527.32±465.39. At the end of the treatment, the means of treating group and the control group were 185.82±136.14 and 341.91±339.15. After lmonth of the end, the means of treating group and the control group were 185.75±127.20 and374.03±365.04.Intra-group comparision:Compared with before treatment,there was of no statistical significance, the value of P is 0.000.Comparison among groups:There was of no statistical significance, the value of P is 0.129 before treating. There was of no statistical significance between the treating group and the control group at the 5th treatment, at the end of the treatment, the P value were 0.325,0.143,0.056. At 1 month after the end of the treatment, there was statistical significance between the treating group and the control group, the value the P was P=0.042.3.4 The reductive ratio of WOMAC questionnaireAt the 5th treatment, the treating group was 40.68±22.06 and the control group was 37.58±26.61. At the end of the treatment, the treating group was 67.25±17.51and the control group was 57.93±24.57. After 1 month of the end, the treating group was 66.23±20.25 and the control group was 50.75±31.1, and There was of no statistical significance between the treating group and the control group at the 5th treatment, at the end of the treatment and 1 month after the treatment, the P value were 0.622,0.091,0.055.4 Comprehensive curtive effect evaluationAt the end of the treatment, the effective rate of the treating group was 100.00%, while the control group was 96.70%, with no statistical significance between and treating group and the control group. The value of P was 1.000. 1 month after the treatment, the effective rate of the treating group was 100.00%, while the control group was 84.40%, with no statistical significance between and treating group and the control group. The value of P was 0.143.5 Adverse eventDuring the study,6 adverse events took place,3 in the treating group with a rate of 8.8%, and 3 in the control group with a rate of 9.1%. There was of no statistical significance between and treating group and the control group. The value of P was 0.143.ConclusionThe study showed that both of the CAJ moxibustion therapeutic instrument and the DAJ multi-function moxbustion instrument could improve symptoms of KOA, the efficacy and safety were equivalent between the two instrument. |
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