| ObjectiveCompared with the DAJ multi-function moxibustion instrument and evaluate the efficacy and safety of the CAJ moxibustion therapeutic instrument for the treatment of Cervical spondylosis neck pain.Methods70 qualified patients are divided into two groups in proportion as 1:1, namely the treatment group(the CAJ moxibustion therapeutic instrument group) and the control group (the DAJ multi-function moxibustion instrument group), and 35 cases in each group.Dazhui(DU14), Jianzhongshu (SI15), Zhongzhu (SJ3) and Positive reaction plane of Bilateral Cervical Jiaji Points were selected in two groups. The treatment group and the control group were treated with the CAJ moxibustion therapeutic instrument and the DAJ multi-function moxibustion instrument separately on the same operation. The amount of fine moxa should be filled in the central alignment of the protective pads which should point to moxibustion acupoints and be pressed tightly. And then make sure that the moxibustion moxas has been fixed in the protective pads with appropriate band. Regulate the temperature of 50 to 54℃, adhere to the principle of no pain and no foaming.The treatment frequency and time:1 time every other day,40 minutes each treatment,3 times a week,3 weeks for 1 courses. After the last treatment the patients were followed up for 1 months. To evaluate with pain score (VAS), Northwick Park neck pain scale(NPQ) and therapeutic efficacy of TCM syndromes, respectively prior treatment, 5 times after the treatment, the end of treatment and post-treatment for 30?3days, and recording adverse effects and side effects during the research.All the data were input into the SPSS20.0 statistical analysis software package, then managed and analyzed by the significance test, non inferiority and two-sided test. To select the appropriate statistical analysis method according to the clinical trial data (measurement properties, classification data and level information). X2 test or exact probability method for categorical data.Results1. Baseline comparison:Statistical analysis shows that there are no significant differences (P>0.05)among age, nationality, occupation, duration of disease, treatment history, comorbidities, allergic history, usual drugs, weight, height, body temperature, respiration, heart rate and pressure, indicating two groups are comparable.2. VAS results show that the treatment group score of prior treatment,5 times after the treatment, the end of treatment and post-treatment for a month are 5.06±1.63,3.26±1.27,1.88±1.16and 1.23± 0.71, While the control group are 5.01±1.46,3.70±1.57,2.74±1.42 and 2.40±1.61.The statistical results suggest that differences in scores after the treatment and post-treatment for a month between two groups had statistical significance(P=0.004, P=0.001), but 5 times after the treatment showed no statistical significance(P=0.225). After treatment, the rate reduction between the two groups show that the treatment group was significantly higher than the control group, and the end of treatment and post-treatment for a month in the rate reduction between the two groups was statistically significant difference(P=0.011, P=0.001).Within group comparison show that the VAS score of the two groups decreased than before, and going downwardly at 5 times after the treatment, the end of treatment and post-treatment for a month. Each time point in the group were compared, which results indicated that there was statistically significant difference(P<0.05).The analysis results suggest that the CAJ moxibustion therapeutic instrument is significantly better than the DAJ multi-function moxibustion instrument in the short and medium term.3. NPQ results show that the treatment group score of prior treatment,5 times after the treatment, the end of treatment and post-treatment for a month are 34.41±11.42、19.72±9.25、10.68±7.87 and 8.93±6.44, While the control group are 37.09±16.60、23.81±10.76、18.25±9.77 and 16.81± 13.02.The statistical results suggest that differences in scores after the treatment and post-treatment for a month between two groups had statistical significance(P=0.001, P=0.003), but 5 times after the treatment showed no statistically significant difference (P=0.225). After treatment, the rate reduction between the two groups show that the treatment group was significantly higher than the control group, and the end of treatment and post-treatment for a month in the rate reduction between the two groups was statistically significant difference(P=0.005, P=0.008).Within group comparison show that the NPQ score of the two groups decreased than before, and going down at 5 times after the treatment, the end of treatment and post-treatment for a month. Each time point in the group were compared, which results indicated that there was statistically significant difference(P<0.05).The analysis results suggest that the CAJ moxibustion therapeutic instrument is significantly better than the DAJ multi-function moxibustion instrument in the short and medium term.The effective rate showed that the treatment group(32 cases)have 28 cured cases,1 markedly effective cases,0 effective cases, the total effective rate is 93.7%. The control group (32 cases) have 27 cured cases,2 markedly effective cases,2 effective cases, the total effective rate is 96.9%.4. Therapeutic efficacy of TCM syndromes results show that the treatment group score of prior treatment,5 times after the treatment, the end of treatment and post-treatment for a month are 15.37±4.99、8.68±6.52、5.43±5.48 and 6.25±6.75, While the control group are 14.93±4.99.9.87 ±5.05、7.81±5.34 and 8.00±6.28.The statistical results suggest that differences in scores 5 times after the treatment and post-treatment for 1 month between two groups had no statistical significant difference (P=0.137,P=0.287), but after the treatment showed statistical significant difference(P=0.034). After treatment, the rate reduction between the two groups show that the treatment group was significantly higher than the control group, but only the end of treatment in the rate reduction between the two groups was statistically significant difference(P=0.046). There was no statistically significant difference in 5 times after the treatment and post-treatment for a month (P=0.122, P=0.145).Within group comparison show that therapeutic efficacy of TCM syndromes’ score of the two groups decreased than before at 5 times after the treatment and the end of treatment, gone upwardly at post-treatment for a month. But the overall trend was still downward trend. Each time point in the group were compared, which results indicated that there was statistically significant difference (P<0.05).The analysis results suggest that the CAJ moxibustion therapeutic instrument is significantly better than the DAJ multi-function moxibustion instrument in the short term, but quite in the medium term.5. The results of safety analysis showed the two instruments have no obvious influence on the body. The clinical research have four cases of adverse events(SS), including 2 cases in the treatment group (the incidence rate was 5.88%)and 2 cases in the control group (the incidence rate was 6.25%). But the difference between the two groups had no statistical significance. And all adverse events had no sequelae after treatment.ConclusionThe CAJ moxibustion therapeutic instrument and the DAJ multi-function moxibustion instrument have the same curative effect and all can decrease the total score of VAS, NPQ and TCM syndrome and Improve clinical symptom. Moreover the two instruments have no obvious influence on the body. Therefore The CAJ moxibustion therapeutic instrument is effective and safe for the treatment of Cervical spondylosis neck pain. |
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