| Objective:to evaluate the efficiency and safety of acupuncture for lumbar disc herniation induced chronic sciatica.Methods:This randomized controlled trial includes 50 patients with lumbar disc herniation induced chronic sciatica.Patients were randomly assigned to acupuncture group or sham acupuncture group.The tailored stick adhesive pads were put in both groups.Acupoints in both groups are Dachangshu(BL 25),Shenshu(BL 23),Weizhong(BL 40),and Chengshan(BL 57).A Huatuo brand needle for BL25 was inserted vertically until the patients have a feeling of electrocution to the lower extremity,then raised the needle 1-2mm upward,without rotating of lifting.Needles in other acupoints were inserted vertically at a depth of 30mm,then lifting,thrusting,twirling evenly until achieving the Deqi sensation.Use blunt needles in the sham acupuncture group.The remaining operation is the same as the acupuncture group.The treatment was last 30 minutes every time.Both groups were treated three times a week for four weeks and followed by 24 weeks.The primary outcome was the average change from baseline in leg pain VAS(visual analogue scale)over weeks 1-4.The secondary outcomes include changes in mean weekly VAS of leg pain and low back pain over weeks 1-4,weekl6,and week28.Oswestry disability index(ODI),The MOS item short form health survey(SF-36),patients global impression of improvement,patient expectations,blinded evaluations,safety evaluations.Results:this trial include fifty participants,and 44 participants completed the study.Demographic and clinical characteristics were consistent at baseline.The change from baseline in leg pain VAS over weekl-4 was 22.22[95%CI 18.14 to 26.29]in the acupuncture group and 15.05[95%CI 9.27 to 20.82]in the sham acupuncture group.Between-group difference was 7.170[95%CI 0.41 to 13.93].There was a significant statistical difference between two groups.The difference between two groups was higher than 5mm.Therefore,the difference has clinical significance.The change from baseline in leg pain VAS over week 16 and week 28 was 22.56[95%CI 14.29 to 30.83]in the acupuncture group and 17.53[95%CI 7.60 to 27.46]in the sham acupuncture group.Between-group difference was 6.17[95%CI-17.49 to 7.43].The difference between group has no statistical significance,but it has clinical significance as the difference was higher than 5mm.The change from baseline in low back pain VAS over week1-4 was 21.35[95%CI 15.78 to 26.91]in the acupuncture group and 17.24[95%CI 11.51 to 22.96]in sham acupuncture.Between-group difference was 4.11[95%CI-3.65 to 11.86].There was no significant statistical difference between two groups.The change from baseline in low back pain VAS over week 16 and week 28 was 20.00[20]in the acupuncture group and 18.50[-17.75]in the sham acupuncture group.Between-group difference was 18.50[-17.75].The difference between group has no statistical significance.The change from baseline in Oswestry disability index(ODI)over week 4 was-13.09[95%CI-18.48 to-7.70]in the acupuncture group and-9.38[95%CI-16.93 to-1.83]in the sham acupuncture group.Between-group difference was-3.71[95%CI-12.58 to 5.17].The difference between two groups has no statistical difference.The change from baseline in ODI over week 16 and week 28 was-9.96[95%CI-16.70 to-3.21]in the acupuncture group and-9.43[95%CI-16.80 to-2.05]in the sham acupuncture group.Between-group difference was-0.528[95%CI-10.20 to 9.15].The difference between two groups has no statistical significance.The change from baseline in aggregate score of the Short Form of Health Survey(SF-36)was 8.39[95%CI 0.63 to 16.14]in the acupuncture group and 12.28[95%CI 4.79 to 19.77]in the sham acupuncture group.Between-group difference was-3.90[95%CI-14.40 to 6.60].The difference between two group has no statistical significance.Blinding method evaluation:there was no significant difference between two groups of the blinding method.Therefore,the blind process was successful.Expectation evaluation:there was no significant difference between two groups in expectation evidence.Therefore,the primary outcome could exclude from the expectation effect.There were no serious adverse events in both groups.Two participants bleeding after the needle pulling out and stopped bleeding by applying pressure.The incidence of adverse events was 7%in the acupuncture group and 0%in the sham acupuncture group.There was no statistical difference between the two groups.Conclusion:acupuncture might have clinical significance in relieving lumbar disc herniation induced sciatica.However,the large sample size trial is necessary for reliable evidence.Trial registration:AMCTR-IPR-17000107... |
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