| Objective:This study is a clinical randomized controlled trial(RCT).Participants who diagnosed chronic neck pain(CNP)are regarded as the object of research.There are 3 groups(acupuncture at 5 high-pain-sensitization acupoints,acupuncture at 5 low-pain-sensitization acupoints and sham acupuncture)in our study.By comparing the 3 interventions for CNP patients in efficacy and safety,we want to provide clinical doctors with high-quality evidence to promote the improvement of acupuncture for CNP and expand the development of theories related to acupoints sensitization.Methods:In this study,we adopted a prospective,randomized,controlled,and parallel-designed clinical research model.The dynamic block randomization was carried out through the central randomization system.164 CNP participants who fully met the criteria were divided into group A(acupuncture at 5 high-pain-sensitization acupoints)with 53 cases,group B(acupuncture at 5 low-pain-sensitization acupoints)with 56 cases and 55 cases in the C group(sham acupuncture)randomly.According to the participant’s self-reported pain region/point,five detection regions and four distal acupoints,sham acupoints were ordered with acupressure palpation and tenderness measurement.Based on previous researches,compared with baseline tenderness threshold,5 pain-sensitization acupoints with the most significant difference were used as A group acupoints,5 pain-sensitization acupoints with the least significant difference were selected as B group acupoints,sham points were selected as C group.10 times of treatment were performed,and the frequency in each group was three times per week in first two weeks,and 2 times per week in next two weeks,the time of needle retention was set as 30 minutes.The changes in the visual analogue score(VAS)of neck pain from the baseline period to the follow-up period was used as primary outcome,and the change of the Neck Disability Index(NDI),Short Form 12 Questionnaire(SF-12),Zung Self-Rating Anxiety Scale(SAS),Zung Self-Rating Depression Scale(SDS)were as the secondary outcomes.In safety,the number of adverse events was assessed as outcome.The scores of all outcome indicators were assessed in the baseline period,treatment period,and follow-up period to analyze the efficacy and safety of acupuncture at pain-sensitization acupoints for CNP patients.In addition,observing the use of the pain-sensitizing acupoints provides a reference for the clinical selection.All outcomes were analyzed using full analysis set(FAS).Results:1.In baseline analysis,a total of 164 CNP patients were included in this study.After excluding the number of missing participants,the final included sample size in the FAS analysis was 145 cases(49 cases in group A,48 cases in group B,and 48 cases in group C).There was no statistical difference in the data of the 3 groups in the baseline period.2.The change of the VAS scores showed that the 3 interventions could reduce the pain intensity,and with the increase of entry time,the degree of improvement of neck pain(change of VAS)between the 3 groups is statistically different(P<0.05).Both groups A and B were statistically different from group C(P<0.05).A,B groups were better than the C group in reducing neck pain.3.The change of NDI showed that the 3 groups can improve the neck function.There was statistical difference(P<0.05)in the improvement of the neck function(the change of NDI)between the 3 groups in 12-24 weeks after enrollment.At 4 weeks of enrollment,both groups A and B were statistically different from group C(P<0.05);while in 12-24 weeks of enrollment,group A and group C had significant statistical differences(P<0.01).4.The change of SF-12 scores showed that the 3 interventions could improve the patients’ quality of life,but the change of SF-12 scores was not significant different between the 3 interventions(P>0.05).5.The change of SAS scores showed that the 3 groups could all improve the anxiety symptoms of patients,and the improvement of anxiety symptoms(change of SAS)between the three groups was statistically different at 4 and 24 weeks after enrollment(P<0.05).Among them,at 4 weeks of enrollment,both groups A and B were statistically different from group C(P<0.05);while at 20 and 24 weeks of enrollment,the SAS scores between groups A and C was statistically different(P<0.05).6.The change of SDS scores showed that the 3 groups of intervention methods could improve the patients’ depressive symptoms,but the change of SDS scores between the 3groups was not statistically different(P>0.05).7.The similarity between the pain-sensitization acupoints is related to the sensitization detection area.Distribution of pain-sensitization acupoints: The top 5 high-pain-sensitization acupoints used frequently are SJ 15,Sensitive Point,BL 11,SI 14,and SI 15;the top 5low-pain-sensitization acupoints used frequently are GB 12,LI 10,GB 20,TE 3,LU 7.8.A total of 3 adverse events occurred,one in each of the three groups,and no serious adverse events occurred.Conclusions:1.According to degree of pain-sensitization,individualized acupuncture has a positive effect on CNP and has a long-term sustained effect.2.Individualized acupuncture has significant advantages over sham acupuncture in reduction of neck pain,improving neck function,and regulating anxiety.However,there is no significant difference between acupuncture at high-pain-sensitization acupoints and low-pain-sensitization acupoints in efficacy from Chengdu center.3.High pain-sensitization acupoints mainly appear in the local area,while low pain-sensitization acupoints mainly appear in the remote points of the related meridians and local area.According to the analysis of clinical efficacy,it is suggested that,when we selecte pain-sensitization acupoints,we should select local acupoints firstly,and then find the remote acupoints(through the related meridians)as a supplement.4.In this study,acupuncture plays a key role for CNP participants in safety. |
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