| BackgroundOsteoarthritis(OA)tends to occur in heavy,mobile joints,such as the distal and proximal interphalangeal joints of the hand,ankle,knee,hip and shoulder joints.Its prevalence increases with age.Joint pain is the main clinical manifestation,which seriously affects the life of patients.Meta-analysis has confirmed that electro-acupuncture(EA)can alleviate joint pain of OA.However,there is not any study on EA for the treatment of HOA.The clinical efficacy of EA for patients with HOA is controversial and needs to be verified by high-quality randomized controlled trials.ObjectTo investigate the difference between the therapeutic effect of EA and topical diclofenac sodium gel(DSG)in relieving pain of hand osteoarthritis(HOA),and to clarify the post-effect of EA.MethodsProspective RCT with block randomization,efficacy evaluators and data handlers blind were performed.Subjects were randomly assigned to the EA group or topical DSG group with a 1:1 allocation ratio.Participants in the EA group received EA treatment(ashi point,EX-UE9,SI3 and SJ5)thrice weekly for 4 weeks.The electrical stimulation lasted for 30 min with a continuous wave of 10 Hz and a fixed current intensity of 0.5-2 mA.In the topical DSG group,topical DSG over the affected joints per hand was applied four times per day for 4 weeks.The primary outcome was the change in average overall finger joint pain intensity in the dominant hand over the previous 48 hours from baseline to weeks 4.The secondary outcomes were as follows:The change in average overall finger joint pain intensity in the dominant hand over the previous 48 hours from baseline to weeks 8 and weeks 16;Change in AUSCAN total score,and pain,stiffness,and physical function subscales from baseline to weeks 4,8,and 16;Change in FIHOA from baseline to weeks 4,8,and 16;Change in the number of self-reported painful joints and painful joints at digital pressure and swollen joints from baseline to weeks 4,8,and 16;The proportion of responders at weeks 4,8,and 16;Change in quality of life assessed by the WHOQOL-BREF from baseline to weeks 4,8,and 16.The SPSS 26.0 software was applied for data analysis.ResultsA total of 86 patients with HOA were enrolled and randomly divided into two groups:EA group and DSG group,43 patients in each group.There was no statistical difference between the two groups.Results of the primary outcome:The reduction of VAS score in the dominant hand over the previous 48 hours from baseline to weeks 4 in the EA group was 33.26(95%CI:-38.62,-27.89).The reduction of VAS score in the dominant hand over the previous 48 hours from baseline to weeks 4 in the DSG group was 14.77(95%CI:-20.72,-8.82).The difference between two groups of the average change from baseline was-18.49(95%CI:-26.38,-10.60)with statistically significant(P<0.001)and clinically significant(which exceeded the MCID).Results of secondary outcomes were as follows:1).At weeks 8 and weeks 16,the reduction of VAS score in the dominant hand over the previous 48 hours from baseline in the EA group was 29.76(95%CI:-35.51,-24.00)and 27.92(95%CI:-33.32,-22.52).The reduction of VAS score in the dominant hand over the previous 48 hours from baseline to weeks 4 in the DSG group was 13.81(95%CI:-19.80,-7.82)and 9.46(95%CI:-16.97,-1.94).The difference between two groups in the reduction of the average pain VAS score of the dominant hand over the previous 48 hours was-15.95(95%CI:-24.13,-7.76)and-18.46(95%CI:-27.60,-9.32)at weeks 8 and 16,both of which exceeded the MCID.2).At weeks 4,8 and 16,the decline of AUSCAN total score,pain,stiffness and physical function from baseline in two groups were all reach the MCID.Only the between-group difference in the reduction of AUSCAN stiffness dimension score at weeks 8 was not statistically significant.3).At weeks 4,the reduction of FIHOA in EA group was-4.00(95%CI:-5.13,-2.87),of which in DSG group was-1.42(95%CI:-2.70,-0.14).The difference between two groups in the reduction of FIHOA was-1.42(95%CI:-2.70,-0.14)with statistically significant(P=0.003).There was no statistically significant between two groups of the the reduction of FIHOA score at weeks 8 and 16.4).The decline in the number of self-reported painful joints,painful joints at digital pressure and swollen joints from baseline to weeks 4,8,and 16 has statistical differences within the group.However,the between-group difference in the decline of the number of self-reported painful joints and painful joints at digital pressure was statistically significant only at weeks 4.The between-group difference of which was-2.44(95%CI[-4.60,-0.28],P=0.027)and-2.33(95%CI[-4.29,-0.36],P=0.021),respectively.5).At weeks 4,8 and 16,the proportion of responders in EA group(83.42%,82.92%,80.56%)were significantly higher than that in topical DSG group(62.79%,61.90%,56.76%),the P value were all less than 0.05.6).The increase of psychological dimension score in the EA group was significantly greater than that in topical DSG group only at weeks 4(5.14,95%CI[0.12,10.15],P=0.045).The increase of environmental dimension score in the EA group was significantly greater than that in topical DSG group at weeks 4 and 8(P<0.01).The incidence of treatment-related adverse events was 9.30%in EA group and 6.98%in DSG group.ConclusionEA can effectively relieve the joint pain of patients with HOA,and the analgesic effect is better than DSG.EA may improve the function of finger joint,slow the progress of disease and improve the quality of life.EA has a good safety and post-treatment effect,and the curative effect can be maintained for 12 weeks after discontinuation of treatment. |
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