| Objective:This study is based on a prospective cohort study of electric acupuncture (EA) combined with infrared treatment of lumbar disc herniation (LDH). A long-term follow-up plan is devised for the patients involved in this study, aiming to explore the long-term effects and related risk factors of EA combined with infrared treatment of LDH and to provide clues and basis for the optimization of clinical acupuncture treatment of LDH.Method:The research is prospective cohort study. Clinical cases are the LDH patients in the Third Affiliated Hospital of Beijing University of Chinese Medicine. We collected a total of 118 cases for the study. Exposure factors are EA combined with infrared therapy. Depending on whether or not to be exposed to this factor, patients are divided into the exposure group and the control group.The exposure group includes 80 patients, who receive the EA combined with infrared treatment. The control group includes 38 patients, who receive non-surgical and non-acupuncture treatments, including nerve root dehydration treatment, neurotrophic therapy, Chinese patent medicine treatment, Chinese medicine topical therapy, etc. We visit patients respectively before the first treatment and after the 6th treatment. After the visits ended, patients with acute episodes were followed up on a regular basis, and assessed on the JOA, VAS scores in the 3rd month,6th month, and 12th month since the first treatment. Through JOA, VAS assessment and survival analysis, the present paper attempts to explore the long-term curative effects of EA combined with infrared.Results:1 Statistical analysis of general clinical dataThe study included 118 patients, who are divided into two groups (80 in the exposure group and 38 in the control group) according to the exposure factors. The demographic data of the two groups of patients collected before treatment, including gender, age, nature of work (physical, non-physical), level of physical strength (light, medium, heavy), duration, BMI index, waist history of trauma, the number of lesions segment, Traditional Chinese Medicine (TCM) syndrome, LDH and relevant information (including the pre-treatment of JOA scores, VAS scores), are of no statistical significance (P>0.05), that is, the baseline-before- treatment indexes are basically the same, indicating that the two groups of LDH patients were comparable.2 Curative effect evaluations2.1 Short-term effects2.1.1 Comparison between JOA scores before the first treatment and after the 6th treatmentThe mean and standard deviation of JOA scores of the two groups are compared before the first treatment and after the 6th treatment.By comparison within the group, the JOA scores after the 6th treatment improved significantly in both groups as compared with that before the first treatment. The differences were statistically significant (P<0.05). The results suggest that the two treatments were effective.By comparison between groups, the JOA scores of the exposure group and the control group before the first treatment showed no difference of statistical significance (P>0.05). The JOA scores of the exposure group and the control group after the 6th treatment also showed no difference of statistical significance (P>0.05). Results suggest that the degrees of improvement in lumbar function of the two groups within the current sample size were comparable.2.1.2 Comparison between VAS scores before the first treatment and after the 6th treatmentThe mean and standard deviation of VAS scores of the two groups are compared before the first treatment and after the 6th treatment.By comparison within the group, the VAS scores after the 6th treatment improved significantly in both groups as compared with that before the first treatment. The differences were statistically significant (P<0.05). The results suggest that the two treatments were effective.By comparison between groups, the VAS scores of the exposure group and the control group before the first treatment showed no difference of statistical significance (P>0.05). The VAS scores of the exposure group and the control group after the 6th treatment also showed no difference of statistical significance (P>0.05). The results suggest that the degrees of improvement in pain of the two groups within the current sample size were comparable.In terms of a comprehensive improvement of the JOA, VAS scores, the results suggest that acupuncture combined with infrared therapy showed excellent clinical efficacy by significantly increasing the JOA scores and reducing the VAS scores, that is, acupuncture combined with infrared therapy can significantly improve lumbar function and reduce pain, which is a good short-term efficacy. There is no significant difference in short-term efficacy when compared with the control group, possibly due to insufficient sample size which is unable to reflect the difference in the current research phase.2.2 Long-term effects2.2.1 JOA scoresAccording to repeated measurement and multivariate analysis of variance, the two groups of 3rd month,6th month and 12th month JOA scores were compared.According to the between-subjects effects of the JOA scores, the results between different sets of measurements showed no significant difference (P>0.05). Results suggest that the group factor is of no remarkable significance to changes in the JOA scores.According to multivariate testing within the JOA scores and the main body effect of JOA scores, the measurement results of overall (regardless of the group factor) JOA scores at different time points were statistically significant (P<0.05). The specific differences are as follows:based on pairwise comparisons, comparing 6th month or 12th month with 3rd month respectively, the JOA score differences were statistically significant, that is,6th month and 12th month JOA scores were better than 3rd month; comparing 6th month with 12th month, the JOA score differences were of no statistical difference, indicating that the JOA scores of 6th month and 12th month were comparable. The results suggest that the time factor is of remarkable significance to changes in the JOA scores.Considering both the group factor and the time factor and according to JOA scores multivariate testing and the JOA scores within the main body effect, the differences in trends of changes of different groups at different times were statistically significant (P<0.05). The exposure group JOA scores showed a steady trend over time, the control group JOA scores showed an upward trend over time, but two groups of trend performance ratings are temporarily unable to compare.2.2.2 VAS scoresAccording to repeated measurement and multivariate analysis of variance, the VAS scores of the 3rd month,6th month and 12th month of the two groups were compared.According to the between-subjects effects of the VAS scores, the results between different sets of measurements results showed significant difference (P<0.05). Results suggest that the group factor is of remarkable significance to changes in the VAS scores, and the exposure group is better than the control groupAccording to multivariate testing within the VAS scores and the main body effect of VAS scores, the measurement results of overall (regardless of the group factor) VAS scores at different time points were not statistically significant (P>0.05). The specific differences are as follows:based on pairwise comparisons, comparing 3rd month,6th month and 12th month VAS scores pairwise, the difference was not statistically significant. The VAS scores of three time points comparable. The results suggest that the time factor for the changes of the VAS scores were not significant.Considering both the group factor and the time factor, according to VAS scores multivariate testing and VAS scores within the main body effect, trends in different groups at different time points, the differences were statistically significant (P<0.05). The exposure group VAS scores showed a steady trend over time, the control group VAS scores showed a downward trend over time, but two groups of trend performance ratings are temporarily unable to compare.2.2.3 Survival analysisThe long-term curative effect of EA combined with infrared therapy to delay the next lumbago acute conditions was studied by survival analysis. The starting event is accepting the treatment for the study, the ending event is acute attack of lumbago, and the time period from the start of treatment to acute attack of lumbago is the survival time of patients.Combined with Log Rank test, as well as the survival curve, it can be found that in the exposure group that the survival time was significantly longer than that of the control group. The results suggest that after treatment the first acute attack of lumbago occurs later in the exposure group than in the control group. Combined Kaplan-Meier analysis-single factor analysis and cox proportional hazards model analysis-multiple factor analysis suggest that the group factor, which represents different methods of treatments, is the major factor influencing the survival time.Through survival analysis, we found that in the long-term effect of the impact, acupuncture combined with infrared therapy can produce significant effect in postponing the next acute attack of lumbago.Conclusion:This study was based on a prospective cohort study of acupuncture combined with infrared therapy of LDH. The long-term effect and the associated risk factors of EA combined with infrared therapy were explored by long-term follow-up. The main curative effects were evaluated mainly by JOA scores, VAS scores and survival analysis. The conclusion is as follows:1. EA combined with infrared therapy can significantly improve the lumbar vertebral function, reduce the degree of lumbar pain, has a significant effect in treating LDH.2. EA combined with infrared therapy can produce improvement in lumbar function and lumbar pain degree and maintains its curative effect for a long period of time.3. EA combined with infrared therapy, when compared with non-acupuncture non-surgical therapy, can in a certain extent postpone the next acute attack of lumbago.4. EA combined with infrared therapy, when compared with non-acupuncture non-surgical therapy, exhibits an unclear trend in improving the the JOA scores, VAS scores, which is yet to be confirmed by further clinical trials. |
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