| Objective:In this study,we aim to design a definitive trial to primarily examine if acupuncture at highly sensitive points,compared with low/non-sensitive points or no acupuncture(waiting list),can result in improving effective among patients with knee osteoarthritis(KOA).Additionally,to explore whether the change in acupoint sensitization is related to disease outcome.Methods:In this randomized controlled trial,201 eligible patients with KOA will be randomly assigned to a high-sensitisation group(group A,patients receive acupuncture at high-sensitive acu-points),a low/non-sensitisation group(group B,patients receive acupuncture at low/non-sensitive acu-points)or a waiting-list group(group C,patients receive standard acupuncture after the study is concluded)via a central randomisation system using 1:1:1 ratio.The entire study period was 17 weeks,with a baseline period of 1 week,a treatment period of 4 weeks,and a follow-up period of 12 weeks.The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks.The secondary outcomes are the knee rotation ranges of motion,SF-12 scores,other treatments received for knee osteoarthritis from baseline to 16 weeks.In addition,observe the distribution of sensitive acu-points and changes of the pain threshold of the five acupuncture points,to explore the correlation between the change of acupoint sensitization and disease outcome.The above outcomes were assessed every 4 weeks during the experimental study period.At the same time,all the evaluation indicators were statistically analyzed by using Full Analysis Set(FAS)and Per Protocol Set(PPS).Results:1.The three groups were consistent in the case completion,as well as the subjects' socio-demographic,vital signs,disease characteristics,and efficacy evaluation indicators.2.The high-sensitisation group and low/non-sensitisation group were statistically different from waiting-list group in WOMAC pain scores,WOMAC function scores(p<0.05).The high-sensitisation group was more obvious than the low/non-sensitisation group in the trend of improving WOMAC pain scores,WOMAC stiffness scores,but the difference was not statistically significant(p>0.05).3.The high-sensitisation group and low/non-sensitisation group had higher active knee flexion than waiting-list group at 4 weeks after enrollment,there was no significant difference between the high-sensitisation group and the low/non-sensitisation group(p>0.05).There were no statistically significance among the three groups in the following outcomes: passive knee flexion,active internal rotation and passive internal rotation,active external rotation and passive external rotation ranges of motion(p>0.05).4.The high-sensitisation group and low/non-sensitisation group had higher PCS scores of SF-12 than waiting-list group(p<0.05).The high-sensitisation group was more obvious than the low/non-sensitisation group in the trend of improving PCS scores,but the difference was not statistically significant(p>0.05).The high-sensitisation group and low/non-sensitisation group had higher MCS scores of SF-12 than waiting-list group at 4,8,12 weeks after enrollment,there was no significant difference between the high-sensitisation group and the low/non-sensitisation group(p>0.05).5.The high-sensitisation group was statistically different from waiting-list group in extra health care products treatment such as amino acid glucose(p<0.05).The high-sensitisation group was more obvious than the low/non-sensitisation group in the trend of reducing extra health care,but the difference was not statistically significant(p>0.05).There were no statistically significance among the three groups in the treatment of extra western medicine treatment,Chinese medicine treatment and other acupuncture treatment(p>0.05).6.The acupoints/points with lower pain threshold were mainly distributed in the inner side of the knee joint,both the acpoints with higher frequency and the acupoints with a large number of pain sensitive points around were Weizhong(BL40),Ququan(LR8),Yingu(KI10),Guquan(LR7)and Weiyanf(BL39).7.Compared with the baseline period,the pain threshold of the 1th,2th,3th,and 4th acupoints/points in the high-sensitivity group increased at the end of the experiment(p<0.05);Compared with the baseline period,the pain threshold of the 3th,4th,and 5th acupoints/points in the non-/low-sensitized group decreased at the end of the experiment(p<0.05);the pain threshold between the 1th acupoints/points in the high-sensitisation group and the 5th acupoints/points in the low/non-sensitisation group was statistically different at enrollment of the experiment,but not statistically different at the end of the experiment(p>0.05).Conclusion:1.The high-sensitisation group and low/non-sensitisation group are effective in the treatment of KOA.The high-sensitisation group was more obvious than the low/non-sensitisation group in the trend of improving the knee of pain,stiffness,physical component and reducing extra health care,such as amino acid glucose,but the difference was not statistically significant.Further verification is required after the final data of the entire research project is summarized.2.The top 5 acupoints/points with the highest number of pain sensitive points around are exactly the same as the top 5 most frequent pain-sensitive acupoints/points.We conclude that these pain sensitive points may be caused by the enlargement of the area after sensitization of acupoints,which are actually sensitized acupoints.3.With the improvement of knee osteoarthritis,the sensitive acupoints/points in high-sensitisation group changed from sensitized state to non-sensitized state,and the pain threshold is close to the normal boundary value.The non-sensitive acupoints/points in low/non-sensitisation group still in non-sensitized state,and the pain threshold is at a normal boundary value.It is indicated that the "activated" state of the acupoint under pathological condition may be converted to the "quiet" state of the physiological condition. |
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