| Purposes To evaluate the efficacy of different frequencies of TEAS on acute pain after the total knee arthroplasty,in order to find the best analgesic frequencyMethods This is a prospective,double-blind,randomized,placebo-controlled trial.According to the different frequency of TEAS treatment received by the participants,a total of 100 participants are randomly assigned to four groups: LF group(Low Frequency),HF group(High Frequency),mixed group(Mixed Frequency,alternative use of daily 5 Hz and 100 Hz TEAS),and placebo group.In LF,HF and MF group,electrical stimulation is conducted at acupoints SP9 and GB34 of the operated leg(at a wave of continuous,balanced and asymmetrical biphasic square,with a pulse width of 200 ?s,and a strong but comfortable current amplitude)for 30 minutes prior to a 30-minute-rehabilitation session per day for 2 weeks.In placebo group,electrical stimulation is delivered at a strong but comfortable current for 30 seconds,then the current is gradually decreased to none over the next 15 seconds,the total action time is 45 seconds.The outcomes are measured before surgery,at baseline(post-operative 3 days,before TEAS intervention),week 1 and week 2 after TEAS intervention.The primary outcomes include:(1)the Numeric Pain Rating Scale at rest and with movement;(2)the American Knee Society Score.The secondary outcomes include:(1)Active range of motion of the operated knee;(2)Surface electromyography of both quadriceps;(3)Modified 30-second sit to stand test.The additional outcomes include: Patients' satisfaction rate.To test the blinding effect of participants and assessors,they are asked to guess whether the subjects received active TEAS or placebo TEAS within 5 minutes after the latest TEAS intervention.The safety and financial cost of TEAS are also assessed.Results 1.There was no significant difference in the NRSR scores between the groups(P>0.05).Compared with the NRSR score of POD3,the NRSR score of week2 decreased by 0.458(P<0.001),and the NRSR score of week1 decreased by 0.091(P <0.01).2.There were significant differences between the groups of NRSM scores(P < 0.001).In week 1,100 Hz group,5/100 Hz group had significant differences in NRSM between groups compared with Placebo group(P < 0.05),the NRSM of 100 Hz group was lowest,P =0.001,95%CI(0.618,3.352).In week 2,5Hz group,100 Hz group,5/100 Hz group had significant differences in NRSM scores between groups compared with Placebo group(P < 0.05),the NRSM of 100 Hz group was lowest,P <0.001,95%CI(1.703,4.067).The statistic t value of the mean difference of NRSM between week1 and POD3 of all group except the Placebo group were the largest and statistically significant(P < 0.01).3.There were significant differences AKSS scores between the groups of(F = 4.418,P = 0.005).In the week1,the contrast estimate value(95% CI)between the 5 Hz group and the Placebo group = 16.25(1.306,31.343)was statistically significant(t = 2.141,P = 0.033),and the contrast estimate value(95%CI)between the 100 Hz group and the Placebo group = 28.610(12.907,44.313)was statistically significant(t = 3.588,P<0.001),and the contrast estimate value(95%CI)between the 5/100 Hz and Placebo group = 24.438(8.853,40.023)was significance(t = 3.088,P = 0.002),the contrast estimate value(95%CI)between other groups were not statistically significant.In the week2,the contrast estimate value(95%CI)between the 100 Hz group and the Placebo group = 24.900(11.917,37.882)was statistically significant(t = 3.777,P < 0.001),and the contrast estimate value(95%CI)between the 5/100 Hz group and the Placebo group = 18.779(5.873,31.684)was statistically significant(t = 2.866,P = 0.005),and the contrast estimate value(95%CI)between the 100 Hz group and the 5Hz group = 15.336(2.709,27.963)was statistically significant.(t = 2.392,P=0.017),the contrast estimate value(95%CI)between other groups were not statistically significant.In the 5Hz group,100 Hz group and 5/100 Hz group,the contrast estimate value(95% CI)between week1 and POD3 was the largest(P<0.001),and the results of the Placebo group time point comparison were opposite to those of the above three groups.4.There was a statistically significant difference between the KA scores in each group(P=0.006).Compared with the Placebo group,100 Hz group,5/100 Hz group have a statistically significant difference in KA score in the week 1 and week 2(P < 0.05).The KA score of the 100 Hz group was the highest in week 1(P=0.003,95% CI(3.897,25.677))and week 2(P<0.001,95% CI(5.060,21.842)).The statistic t value of the mean difference of NRSM between week1 and POD3 of all group except the Placebo group were the largest and statistically significant(P<0.001).5.There was a statistically significant difference of FA scores between the groups(F = 2.687,P = 0.047).In the week 1,the contrast estimate value(95% CI)between the 100 Hz group and the Placebo group = 14.018(2.821,25.216)was statistically significant(t = 2.465,P = 0.014),and the contrast estimate value(95% CI)between the 5/100 Hz group and the Placebo group = = 12.983(1.803,24.164)was statistically significant(t = 2.287,P = 0.023),and the contrast estimate value(95% CI)between the other groups were not statistically significant.In week2,there was no statistically significant difference between the groups(P>0.05).In the 5Hz group,100 Hz group and 5/100 Hz group,the contrast estimate value(95% CI)between week1 and POD3 was the largest(P<0.001),and the results of the Placebo group time point comparison were opposite to those of the above three groups.6.There was no significant difference between the groups of AROME(P >0.05).With POD3 as control,the fixedcoefficients of week1 and week2 were-0.663(P >0.05)and-3.997(P <0.001)respectively.7.There was no significant difference between the groups of AROMF(P >0.05).With POD3 as control,the fixedcoefficients of week1 and week2 were 4.165(P<0.05)and 21.097(P<0.001)respectively.8.The differences of i EMG,peak value and RMS in the lower limbs of the same patient at each evaluation time point were statistically significant(P <0.05).There was no significant difference in i EMG,peak value and RMS difference between the lower limbs at each evaluation time point(P > 0.05).There were no significant differences in i EMG,peak value and RMS difference between the lower limbs at different time points in the group(P > 0.05).9.There was no significant difference between the groups of m30 STS test(P >0.05).The absolute value of the statistical t value of the mean difference of m30 STS test score between week1 and POD3 of each group was the largest and statistically significant(P <0.01).10.The Patients' satisfaction rate between the 100 Hz group and the Placebo group was statistically significant(?2=7.260,P <0.01).Conclusions In summary,among the three frequency parameters of 5Hz,100 Hz,and 5/100 Hz,100Hz TEAS is the optimal frequency.It showed the relief of pain after TKA,the improvement of functional level and the highest satisfaction rate of patients.With the increase in the time of TEAS interventions,opioid tolerance or cross-tolerance occurs at the fifth day of intervention.Therefore,in clinical applications,continuous intervention can be controlled for no more than 5-6 days to avoid or delay the tolerance effect. |
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