| Objective1.A systematic meta-analysis was conducted on previous published literatures on the treatment of shoulder pain at ashi point,so as to provide evidence-based medical evidence for the clinical effectiveness of the treatment based on ashi point in shoulder pain.2.To compare the clinical efficacy and safety of superficial and deep acupuncture into ah sih points in patients with rotator cuff injury.Methods1.Systematic evaluationThe retrieval system included China Knowledge Network Database(CNKI),Wanfang,CBM,VIP Network database and PubMed database,Web of Science,Cochrane Library,Embase and other databases were searched,and all relevant literatures related to the treatment of shoulder pain by ashi point or tender point or trigger point were searched from database setup.Endnote X8 software was used for management.After careful reading of the title and abstract of the literature to exclude the literature which did not meet the inclusion criteria,followed by data extraction,such as clinical efficiency,VAS,etc.The RevMan5.3 software was used to Meta analysis.(1)Retrieval Method:The Chinese search formula were:(1)"a point" or "trigger point" or"trigger point" or "pain point":(2)"shoulder pain" or "rotator cuff injury"or "rotator cuff tear" or "acromial impingement syndrome" or "shoulder joint injury".The English search formula were:(1)"ashi point" or "trigger point"or "tender point".(2)"Shoulder pair" or"rotator cuff injury" or "rotator cuff tear" or "acromion impingement syndrome" or "shoulder joint injury".The retrieval method was(1)and(2).(2)Quality EvaluationThe quality assessment criteria for treatment in the randomized controlled trial in the Corchrane evaluation manual were used for evaluation.The evaluation criteria were as follows:(1)whether the patients adopted the random allocation method,whether they used the correct random method(correct random method:random number table,computer-generated random Numbers,coin toss and lottery,etc.;Wrong random method:using the parity of the number of patient's birthday,hospitalization date,hospitalization number,etc.Unclear:it is difficult to judge without providing detailed methods.;(2)whether to use the perfect allocation hidden scheme(perfect:center random,including telephone,network and pharmacy control random;Imperfect:open random distribution sequence,use unsealed,light-transmitting envelope,and alternate distribution;Unclear:no mention of allocation hidden.;(3)whether the correct use of the blind method(correct:did not use the blind method but the results of the judgment and measurement is not affected,the patients and the main researchers to use the blind method,the results of the evaluator to use the blind method;Incorrect:the blind method is not adopted,or the blind method is not perfect,and the result judgment is affected;Unclear:no mention of blinding.;(4)the result data is complete(complete no missing data,or missing data does not affect the result analysis;Incomplete:missing data and affecting the result analysis;Unclear:information is incomplete and difficult to judge.;(5)whether to selectively report the research results(no:there is a research program,and according to the report results,there is no research program,but the expected outcome indicators are;There were:no pre-specified major outcome indicators reported;Not clear.;6.Other sources of bias(none:no other sources of bias were included in the study;There were:early termination of the study with uneven baseline;Unclear).Independent parallel evaluation was conducted by two evaluators,and the differences of opinions were resolved through consultation by both parties.A third literature reader was added to the literature in dispute,and the inclusion was decided after consultation by three people.(3)Statistical AnalysisRevMan 5.3 provided by Cochrane was adopted.Meta analysis and statistical treatment were performed with the software.The heterogeneity test was performed on the data of all included literatures.If I2 was greater than 50%,it indicated that the heterogeneity of the included studies was significant.Random effect model was selected for analysis,and the source of heterogeneity was analyzed.If I2<50%,it indicates that there is no heterogeneity in the included studies,and fixed effect model is used for analysis.According to the data types of outcome indicators,statistical methods were selected for analysis.Odds Ratio(OR)analysis was applied to the classified data.Mean Difference(MD)analysis was performed for continuous variables.The 95%Confidence Interval(CI)was used for all effects.2.Clinical ResearchA randomized,parallel group,blinded,controlled clinical trial was conducted at Kang' s rehabilitation center(Westfield Eastgarden,Australia).According to the preliminary experimental study and the literature related to acupuncture ah sih point,taking Visual analogue scale(VAS)as the primary therapeutic effect indicator.Using a power and sample size software to estimate the sample size.Finally,a total of 90 participants were included in the study,and 30 participants were required in each group according to the ratio of 1:1:1.In this study,SPSS 22.0 statistical software was used to generate random Numbers,and the random Numbers were sealed to light-tight envelopes.The envelopes were handed to the participantsby another researcher.The participants were randomized assigned to superficial acupuncture group or deep acupuncture group according to the sequentially Number.InterventionRehabilitation group:the participants received manipulation release,and followed by passive and active rehabilitation training.Rehabilitation+ashi shallow acupuncture group:In this group,the participants received rehabilitation training,as well as shallow acupuncture in ashi points.Rehabilitation+ashi deep acupuncture group:In this group,the participants received rehabilitation training,as well as deep acupuncture in ashi points.Course of treatment:Each rehabilitation training was sustained 20 min,and takento the 6-week exercise program specifically twice for a week.Acupuncture treatment was performed twice a week,with each treatment interval of 48h or more,and 6 weeks was 1 course of treatment,with a total of 12 times of treatment.Considering the actual clinical situation,patients may have partial shedding rate,so 80%of the total treatment times can be taken into effective observation cases.Evaluation:Primary outcome measure was VAS clinical efficacy,the secondary outcome measures were ROM,UCLA,adverse events,and compliance analysis.All the outcomes were detected at the baseline,after treatment,and lmonth follow up.Statistical analysis:SPSS 22.0 statistical software was used for data analysis.The data were reported as mean± standard deviation(mean ± SD).The baseline patient characteristics were using ANOVA test or chi-square test to compared the results of theree groups.The VAS,ROM,UCLA outcome were analyzed using repeated measures analysis of variance(ANOVA).If the main interaction effect was evident for the outcomes,least significant difference test was performed to compare within/between two groups for the same time points,baseline,post-treatment,and lmonth follow-up.Safety analysis:the case safety analysis of each group was mainly descriptive statistics,including the incidence of adverse events and the specific description of adverse events.Qualitative analysis of the relationship between adverse events and intervention.Compliance analysis:the cases included in the study were analyzed in groups,and the baseline of the shedding cases was analyzed intergroup.Case analysis of shedding cases:for shedding cases,reasons for shedding of all cases should be explained,proportion of shedding cases to total observed cases should be calculated,clinical features of baseline of all shedding cases should be analyzed,and descriptive analysis between groups should be conducted.Outcome1.Meta analysis resultsAccording to the experimental scheme and the Retrieval scheme,a total of 724 references were retrieved for the first time.Forty-seven articles were excluded after repeated review and review of literature titles and abstracts,excluding duplicate publications and non-clinical studies.After further reading the full text,the substandard literatures were excluded,and finally 21 literatures were included,and 2 English literatures was included.The included studies reported clinical total effective rate,VAS,and shoulder function scores,respectively-The total clinical effective rate was reported in all the 21 included literatures,and VAS score was reported in 7 studies.The other literatures could not be combined for analysis due to different scoring indexes of shoulder joint function,so the shoulder joint function was conducted in this meta analysis.Specific relevant outcome indicators are as follows:1)Clinical total effective rate analysisA total of 21 studies calculated the total effective rate before and after treatment by calculating VAS and shoulder joint functional activities.The results of heterogeneity analysis showed that P=1:0.41,I2=4%,suggesting that there was no heterogeneity between the treatment based on ashi point and conventional treatment in the effective rate,so the fixed-effect model was adopted for analysis.Meta analysis showed that OR=4.74,95%CI(3.21-6.99),P<0.00001,suggesting that there was a statistical difference between the two groups.Compared with the conventional treatment group,the treatment based on ashi point had better clinical efficacy in alleviating shoulder pain and improving shoulder range of motion.Publication bias analysis was performed on the included studies.Funnel plot showed that most of them were concentrated in the middle,suggesting no obvious publication bias.2)analysis of VASVAS scores were reported in 7 studies.The results of the heterogeneity analysis showed that P<0.00001,I2-87%,suggesting that there was heterogeneity between the treatment based on ashi point and conventional treatment in the VAS score,so the random effect model was adopted for analysis.Meta analysis showed that MD=-0.65,95%CI(-1.18-0.11),P=0.002,suggesting that compared with the conventional treatment group,the treatment based on ashi point had better clinical effect in improving shoulder pain.2.Clinical trial ResultsPatient characteristics:A total of 90 patients with rotator cuff injuries were included in this study,including 74 patients who completed all the treatment plans and follow-up,and 16 patients who were lost or eliminated.30 cases were included in the Rehabilitation group,and 6 cases were exfoliated;30 cases were included in theRehabilitation+ashi shallow acupuncture group,and 6 cases were exfoliated;30 cases were included in the Rehabilitation+ashi deep acupuncture group,and 4 cases were exfoliated.There was no significant difference between the two groups.According to the principle of ITT,all data collected after patients were randomly assigned to the group were involved in statistical analysis.The chi-square test or ANOVA analysis of the general data such as age,gender,occupation,course of disease treatment history of patients,as well as involved side in the theses groups showed no significant difference between the groups(P>0.05).the VAS,ROM,and UCLA scores were similar(P>0.05)in two groups at baseline.Primary outcome1)University of California Los Angeles(UCLA)score:?UCLA score:Analysis of variance was repeated with two factors,and results of sphericity test showed that P=0.000<0.05 did not satisfy the spherical hypothesis.Therefore,Greenhouse-Geisser was adopted to calibrate the model and the comparison between time points(F=1783.207,P=0.000)and groups(F=17.975,P=0.000)was statistically significant.Time*grouping(F=7.834,P=0.001)was also statistically significant,suggesting interaction,so simple effect analysis was conducted.The results showed that compared with the baseline,the VAS scores at the end of treatment point of the three groups were significantly decreased(P<0.05),and there was no statistical difference between the rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=-O.967,P=0.201),but there was a statistical difference between the two groups(MD=-3.433,P=0.000).At the 1-month follow-up,there was still no statistical difference between the simple rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=-O.200,P=0.741),and there was still a statistical difference between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi deep acupuncture group(MD=-3.567,P=0.000).No matter at the end of treatment or at 1 month of follow-up,there were statistically significant differences between the rehabilitation+ashi deep acupuncture group and the rehabilitation + ashi shallow acupuncture group(MD=-2.467,P=0.001)?(MD=-3.367,P=0.000),respectively.?UCLA clinical efficacy:clinical efficacy was assessed after treatment according to UCLA scores(excellent clinical efficacy was between 34-35 score,good clinical efficacy was between 29-33,poor clinical efficacy was less than 29 score).The results showed that there were 0 excellent clinical efficacy cases,15 good clinical efficacy cases and 15 poor clinical efficacy cases in rehabilitation group.And In the rehabilitation+shallow thorn group,there were 5 cases with excellent clinical efficacy,18 good clinical efficacy cases,and 7 poor clinical efficacy.Rehabilitation+ is the deep thorn group,there were 11 cases with excellent clinical efficacy,18 good clinical efficacy cases,and 1 poor clinical efficacy.Pearson chi-square test was used,and the comparison between groups was statistically significant(P=0.000).2)Range of motion(ROM)of the shoulder:?Shoulder flexion range of motion(SFROM):Analysis of variance was repeated with two factors,and results of sphericity test showed that P=0.000<0.05 did not satisfy the spherical hypothesis.Therefore,Greenhous e-Geisser was adopted to calibrate the model and the comparison between time points(F=776.129,P=0.000)and groups?F=2.965,P=0.057)was statistically significant.Time*grouping(F=4.600,P=0.008)was also statistically significant,suggesting interaction was exist,so simple effect analysis was conducted.The results showed that compared with the baseline,the SFROM at the end of treatment point of the three groups were significantly decreased(P<0.05),and there was no statistical difference between the rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=-1.333,P=0.705),but there was a statistical difference between the two groups(MD=-9.667,P=0.007).At the 1-month follow-up,there was still no statistical difference between the simple rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=MD=0.200,P=0.958),and there was still a statistical difference between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi deep acupuncture group(MD=-10.133,P=0.009).No matter at the end of treatment or at 1 month of follow-up,there were statistically significant differences between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi shallow acupuncture group(MD=-8.333,P=0.020)?(MD=-10.333,P=0.008),respectively.?Shoulder abduction range of motion(SAROM):Analysis of variance was repeated with two factors,and results of sphericity test showed that P=0.000<0.05 did not satisfy the spherical hypothesis.Therefore,Greenhouse-Geisser was adopted to calibrate the model and the comparison between time points(F=611.371,P=0.000)and groups 152,P=0.008)was statistically significant.Time*grouping(F=9.036,P=0.000)was also statistically significant,suggesting interaction was exist,so simple effect analysis was conducted.The results showed that compared with the baseline,the SAROM at the end of treatment point of the three groups were significantly decreased(P<0.05),and there was no statistical difference between the rehabilitation group and the rehabilitation+ ashi shallow acupuncture group(MD=-5.167,P=0.213),but there was a statistical difference between the two groups(MD=-16.167,P=0.000).At the 1-month follow-up,there was still no statistical difference between the simple rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=-1.833,P=0.65),and there was still a statistical difference between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ ashi deep acupuncture group(MD=-16.833,P=0.000).No matter at the end of treatment or at 1 month of follow-up,there were statistically significant differences between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi shallow acupuncture group(MD=-11.000,P=0.009),(MD=-15.000,P=0.000),respectively.?Shoulder Extension Range of Motion(SEROM):Analysis of variance was repeated with two factors,and results of sphericity test showed that P=0.000<0.05 did not satisfy the spherical hypothesis.Therefore,Greenhouse-Geisser was adopted to calibrate the model and the comparison between time points(F=285.756,P=0.000)and groups(F=4.714,P=0.000)was statistically significant.Time*grouping(F=7.960,P=0.000)was also statistically significant,suggesting interaction was exist,so simple effect analysis was conducted.The results showed that compared with the baseline,the SEROM at the end of treatment point of the three groups were significantly decreased(P<0.05),and there was no statistical difference between the rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=-1.500,P=0.458),but there was a statistical difference between the two groups(MD=-11.133,P=0.000).At the 1-month follow-up,there was still no statistical difference between the simple rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=0.900,P=0.601),and there was still a statistical difference between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi deep acupuncture group(MD=-12.000,P=0.000).No matter at the end of treatment or at 1 month of follow-up,there were statistically significant differences between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi shallow acupuncture group(MD=-9.633,P=0.000),(MD=-12.900,P=0.000),respectively.Secondary outcomes?VAS score:Analysis of variance was repeated with two factors,and results of sphericity test showed that P=0.001<0.05 did not satisfy the spherical hypothesis.Therefore,Greenhouse-Geisser was adopted to calibrate the model,and the comparison between time points(F=932.808,P=0.000)and groups(F=67.920,P=0.000)was statistically significant.Time*grouping(F=25.402,P=0.001)was also statistically significant,suggesting interaction,so simple effect analysis was conducted.The results showed that compared with the baseline,the the end of treatment point VAS scores of the three groups were significantly decreased(P<0.05),and there was no statistical difference between the rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=0.100,P=0.667),but there was a statistical difference between the two groups(MD=0.067,P=0.000).At the 1-month follow-up,there was still no statistical difference between the simple rehabilitation group and the rehabilitation+ashi shallow acupuncture group(MD=0.067,P=0.724),and there was still a statistical difference between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi deep acupuncture group(MD=2.333,P=0.000).No matter at the end of treatment or at 1 month of follow-up,there were statistically significant differences between the rehabilitation+ashi deep acupuncture group and the rehabilitation+ashi shallow acupuncture group(MD=1.967,P=0.000)and(MD=2.267,P=0.000),respectively.?VAS clinical efficacy:The clinical efficiency of VAS was assessed by using nimodipine method.The results showed that:There were 5 cases of obvious effect,24 cases of effective,1 cases of ineffective,and the total effective rate was 96.7%in rehabilitation group.There were 13 cases of obvious effect,17 cases of effective,0 cases of ineffective,and the total effective rate was 100%in rehabilitation+ashi showll acupuncture group.There were 26 cases of obvious effect,4 cases were effective,0 cases were ineffective,and the total effective rate was 100%in rehabilitation+deep acupuncture group.Pearson chi-square test was used,and there was statistically significant difference between the three groups(P=0.000).Safety analysis:Both rehabilitation+shoallow acupuncture group and rehabilitation+deep acupuncture group has 1 case of subcutaneous hematoma occurred in intervention period.1 case of needle sickness occurred in deep puncture group.All the adverse events were recovered well after treatment,without affecting the research results.No serious adverse event was observed.Compliance analysis:A total of 90 participants were included in this study,10 participants were exit,including 6 patients in the rehabilitationgroup,6 patients in the rehabilitation+ashi shallow acupuncture group and 4 patients in the 6 patients in the rehabilitation+ashi deep puncture group.The lost rate is 17.78%,suggesting the compliance is good.No significant difference was found in this two groups.Conclusion1.The Meta analysis results showed that the treatment based on ashi point had a better clinical efficacy rate in the treatment of shoulder pain,and the improvement of shoulder joint pain,and was better than the conventional treatment.2.Rehabilitation or combined ashishallow/deep acupuncture has nice clinical efficacy in rotator cuff injury patients.After 6 weeks intervention,the pain was signifficanty reduced,and shoulder activity function of flexion,abduction,andextension was also marked improved,especially in the rehabilitation+deep acupuncture group.The asih points deep acupuncture is nice choose for rotator cuff injury patients. |
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