| Objective:This randomized controlled trial aims to compare the difference of clinical efficacy between milli-fire needle and simple acupuncture in the treatment of knee osteoarthritis of cold-dampness blockage type,evaluate the method of milli-fire needle on how it alleviate pain,improve joint function and promote synovial inflammation absorption compared with the method of simple acupuncture,and clarify the efficacy and safety of milli-fire needle in treating knee osteoarthritis of cold-dampness blockage type,with a view to provide scientific basis for improving and rolling out treatment of this type knee osteoarthritis in clinical practice,Methods:According to the random number table,60 patients with knee osteoarthritis of cold-dampness blockage type who met the inclusion criteria were randomly devided into experimental group and control group,30 patients in each group.Patients in experimental group were treated with milli-fire needle plus infrared light irradiation,while those in control group received simple acupuncture plus infrared light irradiation.Patients of the two groups chose the same acupoints for treatment,both chosing Liangqiu(ST 34),Xuehai(SP 10),Neixiyan(EX-LE4),Dubi(ST 35),Yanglingquan(GB 34),Yinlingquan(SP 9),Zusanli(ST 36)and Ashi point in the affected side.In the experimental group,the selected acupoints were pricked with milli-fire needle,in which the acupoints near the knee joint,such as Neixiyan(EX-LE4)and Dubi(ST 35),adopted the method of shallow puncture,and the depth of acupuncture is about 10mm,fast in and out without leaving a needle.The rest of the acupoints retained the needle for 5 minutes and then took them out,the depth of acupuncture depends on the thickness of the muscles in the area where the acupuncture points are located,which is about 10 to 20mm.In addition,we used infrared light to irradiate the knee for 25 minutes,and adjusted the fixed power to 15 W.In the control group,the selected acupoints were needled with filiform needle,The depth of the needle insertion depends on the thickness of the muscles in the area where the acupoints are located,which is between 20 to 3 0mm,and the needle is retained by 25 minutes.During the needle retention period,the knee was irradiated with infrared light,and the irradiation time and power were the same as those in the experimental group.Patients in both groups were treated 3 times a week,once every other day for 4 consecutive weeks.The WOMAC scores,VAS scores,synovial thickness and joint effusion depth were recorded in two groups before treatment,after 2 weeks of treatment and after 4 weeks of treatment.The improvement of clinical symptoms of patients in the two groups were then compared and analyzed before and after treatment.Meanwhile,the reduction rate of total WOMAC scores of each group after 2 weeks and 4 weeks of treatment was calculated according to Nimodipine method,in order to compare the overall efficacy of the two groups at each time point after treatment.All the data were statistically analyzed by SPSS 23.0 software,and P<0.05 was considered as statistically significant.Results:1.Intra-group comparison:The total scores of WOMAC,WOMAC scores of pain,stiffhess and functional activities,VAS scores,synovial thickness and joint effusion depth of the two groups which after 2 weeks of treatment and after 4 weeks of treatment were all significantly different from those before treatment(P<0.05).The WOMAC scores of pain,stiffness and functional activities,total scores of WOMAC,VAS scores,synovial thickness and joint effusion depth of each group after 4 weeks of treatment also largely differed from those after 2 weeks of treatment(P<0.05).It is suggested that both milli-fire needle and simple acupuncture can effectively relieve the various symptoms of patients with knee osteoarthritis of cold-dampness blockage type.2.Comparison between groups:(1)After 2 weeks of treatment,the WOMAC pain scores,WOMAC total scores,VAS scores and joint effusion depth in the experimental group were significantly better than those in the control group(P<0.05),but there was no significant difference in WOMAC stiffness scores,WOMAC functional activity scores and synovial thickness between the two groups.(2)After 4 weeks of treatment,there were significant differences in WOMAC pain scores,WOMAC functional activity scores,WOMAC total scores,VAS scores,synovial thickness and joint effusion depth between the experimental group and the control group(P<0.05),but there was no significant difference in WOMAC stiffness scores between the two groups(P>0.05).(3)The overall efficacy of the experimental group after 2 weeks of treatment and 4 weeks of treatment were both significantly better than those in control group at the same point of time,with statistically significant differences(P<0.05).Conclusions:Compared with simple acupuncture,milli-fire needle has a better clinical efficacy in treating knee osteoarthritis of cold-dampness blockage type.The effect of milli-fire needle on the improvement of joint stiffness was similar to that of simple acupuncture,but It is obviously superior to simple acupuncture therapy in relieving pain,improving joint function and activity,alleviating synovial lesions,reducing joint effusion,and promoting the absorption and dissipation of synovial inflammation.Moreover,milli-fire needle therapy is clinically safe and reliable,which makes it feasible and necessary to apply this method more broadly in treating patients with knee osteoarthritis of this type.High-frequency B-ultrasound can quantitatively detect the changes of synovial thickness and joint effusion depth of patients,which can be used as an objective and quantitative evaluation method for efficacy and be further rolled out in clinical practice. |
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