| Objectives: To examine the effects of laser moxibustion(LM)on pain and function in patients with knee OA.To explore whether 10.6 um laser moxibustion can inhibit both the sensory/discriminative and the emotional dimensions of pain in MIA-induced inflammatory pain rats.Methods: Clinical Research: A double-blind randomized clinical trial was conducted from 2016 to 2018 in two outpatient clinics.The participants with knee OA were randomly assigned to LM or sham LM groups(1:1).Twelve sessions of laser moxibustion treatments on the acupuncture point ST35(Dubi)and an Ashi(tender)point at the affected knee(s)were performed three times a week for 4 weeks.The sham control used a non-active laser device for the same schedule.WOMAC,VAS,SF-36 quality of life questionnaire were used to assess the pain,function,stiffness and quality of life of participants of two groups before and after treatment.Adverse effects(AE)were assessed during the entire trial.Blood samples were collected at baseline and week 4 to examine the changes of serum biochemical components levels such as COMP,MCP-1.Animal Research: 1.Twenty-one rats were randomly divided into three groups,na?ve group(n=6),MIA group(n=7),LM group(n=8).From the second day after MIA injection,rats were treated 5 minutes once a day for 7 days and were observed until 14 days after completion of treatment.From the end of the first day of treatment to the end of the follow-up,Hind Limb Body Weight-bearing test(BWB)was measured every day for 21 days.Thermal Withdrawal Latency(TWL)was measured on day7 and day 21.2.Eighteen rats were selected and 15 of them were randomly divided into three groups,na?ve group(n=5),MIA group(n=5),LM group(n=5).On the first day,the time the rats were stay in two special boxes for 10 minutes was recorded.On the second day,the rats were allowed to explore box A for 30 minutes(before the treatment of "non-painful environment" conditional adaptation)and then put back into cage,rest for 3 hours before MIA injection.On the third day,the rats were given 10 minutes of LM treatment,20 minutes of rest after treatment,the rats were allowed to explore box B for 30 minutes(after treatment of the "painful environment" conditional adaptation).On the fourth day,the time rats were stay in the two boxes for minutes was recorded again.CPA score: The time rats stay in the pain-matched box at the second test minus the time in the first test.3.Six rats were randomly divided into two groups,MIA group(n=3),LM group(n=3).Open-field tests were performed 7 days and 8 days after the treatment and 7 days after the the last treatment.Results: Clinical Research: Among the 203 randomized participants,103 were divided into LM group,100 into the sham LM group.There was no significant difference between the two groups in VAS,WOMAC,SF-36,the serum cytokines including COMP、MCP-1 at baseline(P>0.05).the VAS,WOMAC pain,function and stiffness score in the LM group were lower significantly than sham LM group(P<0.05)at week 2,week4 and follow-up after treatmen.There is significant difference in PF between the two groups at week 4 and week 24(P=0.04,0.006).There is significant difference in RP between the two groups at week 4,week 12 week 24(P=0.016,0.039,0.009).There is significant difference in BP between the two groups at week 4 and week 24(P=0.006,0.003).There is significant difference in SF between the two groups at week 4 and week 24(P=0.012,0.005).The the physical component summary(PCS)score in the LM group were higher significantly than sham LM group at week 4 and week 24(P=0.043,0.006).There was no difference in mental component summary(MCS)score between the two groups(P=0.496～0.431).COMP improved in the LM group as compared to the sham control group(P=0.017)after treatment.In LM group,the improvement rate of WOMAC function of the participants whose syndrome differentiation of TCM is stagnancy in muscles and bones is significantly higher than the participants whose syndrome differentiation of TCM is kidney and marrow deficiency(P=0.008).In LM group,the improvement rate of WOMAC pain of the participants whose KL grade was 2 or 3 was significantly higher than whose KL grade was 1(P=0.009,0.036).Animal Research: 1.There was no significant difference between the groups in BWB before treatment(P>0.05).Na?ve group and MIA group showed significant differences in day 1-day21(P <0.001).Na?ve group and LM group showed no significant differences in day 17-day21(P>0.05).LM group and MIA group showed no significant differences only in day4(P>0.05).There was no significant difference between the groups in TWL at baseline(P>0.05).At the the first weekend(the end of the treatment),there was no significant difference in LM group and MIA group compared with Na?ve group(P=0.052,0.236).At the third week(the end of follow up),there was significant difference between the Na?ve group and MIA group in TWL(P <0.001),there was no significant difference between the Na?ve group and LM group in TWL(P=0.154),there was significant difference between the LM group and MIA group in TWL(P=0.013).2.Before treatment,there was no significant difference in the time the rats stay in the pain-matched box between the three groups(P>0.05).There was significant reduction in the time stay in the pain-matched box in MIA group(P=0.01).The CPA score was significantly improved in LM group compared to MIA group(P=0.01).3.7days and 8 days after treatment,there was no significant difference in the central time,central distance,peripheral time and peripheral distance between groups(P>0.05).At 7 days after treatment,the central time in the LM group was significantly higher than MIA group(P=0.001).There was no significant difference in the central distance and peripheral distance between groups at 7 days after treatment(P>0.05).Conclusion: Among patients with knee OA,10.6 um LM resulted in a statistically and clinically significant pain,stiffness reduction and function improvement.LM treatment may also enhance the quality of life in patients with knee OA,especially for physical health.The effect lasted for up to 24 weeks.10.6 um LM had a better therapeutic effect on knee OA patients whose syndrome differentiation of TCM is stagnancy in muscles and bones and yang deficiency and cold coagulation.10.6 um LM had a better therapeutic effect on knee OA patients whose KL grade was 2 or 3.The clinical effect of 10.6 um LM may be related to the decrease of COMP in patients’ serum.Our study suggested that the effect of the 10.6 laser may be associated with protecting cartilage from degeneration in patients with knee OA.10.6 um LM can significantly reduce pain in MIA rats and alleviate the negative emotions such as avoidance and anxiety in MIA-induced inflammatory pain rats. |
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