| ObjectivesTo preliminary evaluate the effectiveness and safety of electro-acupuncture and manualacupuncture in the treatment of knee joint pain.MethodsUsing prospective,randomized,parallel controlled design.Cover 55 patients in middle and old age with knee osteoarthritis,and assign them to electro-acupuncture group,manualacupuncture group and non-acupoint superficial acupuncture group randomly.In the electroacupuncture group and the manual-acupuncture group,using the semi-standardized acupoint selection method.The main acupoints are ST35,EX-LE4,LR8,GB33 and a local A shi acupoint.According to the principle of syndrome differentiation along meridians,three matching acupoints are selected from the given alternative acupoints.In the non-acupoint superficial acupuncture group,needle the eight pre-determined non-acupoint acupoints.In the three groups,only the electro-acupuncture group has the current passing through.The study period is 26 weeks,including 8 weeks of treatment and 18 weeks of follow-up.The courses of treatment of the three groups are the same.In 8 consecutive weeks,completed the acupuncture treatment 3 times a week,and 1 time lasted for 30 minutes,in total of 24 times.The curative effect indexes of this experiment are the total score of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),the score of pain,stiffness and function sub-table,the numerical rating scale(NRS)of knee joint pain,the score of the short form of health evaluation 12 in both physiological and psychological dimensions,and the patients’ global assessment.ResultsThis study involved 55 patients,and 2 patients withdrew their informed consent before the fourth week’s visit,53 patients were included in the full analysis set,of which 5 patients did not complete all the treatment and evaluation,48 patients were included in the per protocol set.Evaluation of efficacy indexes:(1)At the end of the 8 th week,the proportion that the total score of WOMAC decreased by greater or equal to 50%compared with the baseline in the electroacupuncture group,the manual-acupuncture group and the non-acupoint superficial acupuncture group were 33.3%,47.4%and 25.0%separately(in the full analysis set),and there was no statistical difference among the three groups(P=0.374);in the per protocol set,that were 37.5%,50.0%and 50.0%,and there was no statistical difference among the three groups(P=0.344)either.(2)At the 4th week of treatment,the 16th and the 26th week of follow-up period,the proportion that the total score of WOMAC decreased by greater or equal to 50%compared with the baseline were 33.3%,33.3%and 27.8%in the electro-acupuncture group,5.6%,15.8%and 21.1%in the manual-acupuncture group,and 5.6%,15.8%and 21.1%in the non-acupoint superficial acupuncture group.There were no statistical significance of the change values among the three groups.(3)The total score of WOMAC compared with the baseline:only the two evaluations of the electro-acupuncture group in the follow-up period had statistical difference(P<0.05)within the group comparison.As for the comparison of change values among groups,only in the 4th week the electro-acupuncture group was 10.13(2.28,17.99)higher than that of the manual-acupuncture group,the difference had statistical significance(P=0.008),and there were no statistical significance among the three groups at other visit points(P>0.05).(4)The score of WOMAC pain sub-table compared with the baseline:within group eomparison,the scores of 8 th week,16th week and 26th week of electroacupuncture group and the scores of 8th week,16th week and 26th week of manual-acupuncture group compared with the baseline had the statistical significance(P<0.05);the comparison among groups at all visit points had no statistical significance(P>0.05).(5)The score of WOMAC stiff sub-table compared with the baseline:within the group comparison,the scores in the 16th week of the electro-acupuncture group and that in the 8 th and 26th weeks of manualacupuncture group compared with the baseline,had the statistical significance(P<0.05);the comparison among groups at all visit points had no statistical significance(P>0.05).(6)The score of WOMAC functional sub-table compared with the baseline:within the group comparison,the scores of the 26th week in the electro-acupuncture group were statistically significant compared with the baseline(P<0.05).In comparison of the three groups in the 4th week,the difference was P=0.030<0.05,and after the significance of the pair-wise comparison was corrected by Bonferroni,the difference has no statistical significance(P>0.0167).(7)The NRS score of knee joint pain compared with the baseline:the comparison in each group at every visit point had the statistical significance(P<0.05),but no statistical significance among the three groups(P=0.05).(8)The score of physical component summary of 12-Item Short Form Health Survey(PCS-12)compared with the baseline:within the group comparison,the scores of the 8th and 16th week in the electro-acupuncture group compared with the baseline had statistical significance(P<0.05);the comparison among groups at all visit points had no statistical significance(P>0.05).The score of mental component summary of 12-Item Short Form Health Survey(MCS-12)compared with the baseline:within the group comparison,the scores of the manual-acupuncture group in the 16th week were statistically significant(P<0.05);the comparison among groups at all visit points had no statistical significance(P>0.05).(9)The overall efficacy evaluation of the subjects was only statistically different in the 8th week(P=0.032).The subjects in the manual-acupuncture group were not inclined to think that"treatment has a little efficacy"(adjusted standardized residual=-2.3),the subjects in the nonacupoint superficial acupuncture group were inclined to think that "treatment has a little efficacy"(adjusted standardized residual=3.0),and the subjects in the electro-acupuncture group were inclined to think that "treatment has a large efficacy"(adjusted standardized residual=1.9),non-acupoint superficial acupuncture group was not inclined to think that "treatment has most efficacy"(adjusted standardized residual=-1.8);there was no statistical difference among the three groups in the 4th week and the 16th week(P>0.05).(10)In the aspect of safety evaluation,there was only 1 case of adverse events related to acupuncture in the electroacupuncture group,with the incidence of 5.56%,and no case in manual-acupuncture group or non-acupoint superficial acupuncture group.The differences among the three groups had no statistical significance(P=0.665).ConclusionsThe clinical effects of electro-acupuncture,manual-acupuncture and non-acupoint superficial acupuncture are similar in improving the symptoms of knee osteoarthritis and the life quality of patients.But there are some trend differences which cannot be ignored within the group comparison:electro-acupuncture has obvious effect in the aspect of reducing pain and stiffness,improving function,modulating physical condition and scores better in the patients’ global assessment;manual-acupuncture performs good in the aspect of reducing pain,improving function,modulating mental condition and scores even better in the patients’ global assessment;in the overall evaluation of the degree of pain intensity,the three intervention measures all have obvious effect.Overall,acupuncture has the better trend in intervention effect than the sham needling,and electro-acupuncture has the better trend in intervention effect than manualacupuncture,but the difference needs to be further verified by rigorous clinical trials with larger sample size;the three intervention methods all have good safety. |
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