| ObjectiveA simple randomized controlled method was used to compare three groups where sinew acupuncture was used as the treatment group,conventional acupuncture was used as control group 1,and sham acupuncture was used as control group 2 to explore the effect of sinew acupucnture on the joint mobility,VAS score and upper extremity function to compare the therapeutic effects of different methods for treatment rotator cuff injury.The study also aims to provide evidence for the efficacy and safety of sinew acupuncture for soft tissue diseases.MethodsThe cases were collected from November 2018 to August 2019 in the Clinics of the School of Chinese Medicine,Hong Kong Baptist University.Patients aged 15 to 65 years who fulfilled the diagnostic criteria of rotator cuff injury with shoulder pain lasted more than 1 month and diagnosed with Neer stage I or II,with no open soft tissue injury and history of shoulder surgical trauma were included into the study.A total of 120 patients were recruited.Random number table and envelope concealment method was used to divide patients into three groups according to the ratio of 1:1:1 with 40 cases in each group.The treatment group was treated with sinew acupuncture.The treatment was based on jingjin(i.e."meridian sinew")model,which involved needling locally pain and tender points in myofascial tissue along the jingjin pathway.In control group 1,conventional acupuncture was used.According to the meridian system and the painful area,several acupoints namely Tianzong(SI11),Jianyu(LI15),Jianzhen(SI9),Jianliao(TE14),Binao(LI14),Quchi(LI11),Waiguan(TH5),Houxi(S13)and Yanglingquan(CB34)were selected on the affected limb.In control group 2,Sham acupuncture was used.A course of treatment lasted 4 weeks with 8 times of treatment in total.According to the main symptoms of rotator cuff injury,such as pain and joint dysfunction,the parameters of joint mobility,VAS score,upper limbs function assessment were used as the main efficacy evaluation indicators.The improvement of pain before and after treatment was observed.Joint mobility was measured on shoulder flexion,shoulder extension,shoulder abduction and shoulder adduction.Upper limb function score(DASH questionnaire)was also measured.Finally,the frequency of occurrence of tendon nodes around the shoulder joint was counted to observe the common meridian lesions of the disease and provide a basis for the meridian treatment of the disease.All data of treatment results were statistically analyzed using SPSS 23.0 statistical software package.Continuous variables were expressedasnean±standard deviation.The comparison of data between the three groups before and after treatment was performed using the paired t test.One-way analysis of variance was used for the comparison between the three groups.The analysis of variance F test was used when the variances were equal,and the LSD-t test was used for the comparison between the two groups;the Welch test was used for uneven variance.If the data were not normally distributed,M(P25,P75)was expressed and the rank-based non-parametric test was used as statistical method.When the data of the three groups before and after treatment were not normally distributed,the data of the three groups before and after treatment were tested by Wilcoxon rank sum test.For comparison,the Kruskal-wallis test was used for the ranking data among the three groups,and the MannrWhitney U test was used for the comparison between the three groups.P<0.05 indicated that the difference was statistically significant.The effects between the three groups as well as between the treatment group and the control group 1,the treatment group and the control group 2 were analyzed as follows:improvement of the VAS score,joint mobility and the range of upper limb function assessment at the end of the treatment period.The patients were followed up for 6 months to observe the sustained analgesic effects and injury recurrence.Adverse events were also closely monitored.ResultsThere were a total of 120 patients who successfully completed 1 course of treatment.Treatment group(sinew acupuncture):18 males and 22 females withanaverageageof41.00±9.94;averagecourseofdiseasel3.28±3.1 months;control group 1(conventional acupuncture):20 males and 20 females with an average age 43.5±10.06;average course of disease was 15.95±5.94 months;the control group 2(sham needle):19 males and 21 females with an average age 42.00±8.52;average course of disease was 13.57±4.81 months.After statistical analysis,the age and course of disease of the three groups before treatment were normally distributed,and the distribution of gender,age and course of disease were comparable(P>0.05).Subsequent to the 1 course of treatment,the results showed:Comparative analysis of shoulder flexion activity:The difference of shoulder flexion angle of the treatment group was 44.90±27.65,which was better than that of control group 1 32.23±23.21 and control group 2 29.98±27.42.The difference was statistically significant(P=0.032<0.05,P=0.012<0.05);Comparative analysis of shoulder extension activity:the difference of shoulder extension angle of the treatment group was 32.05±12.28,the angle of the control group 1 was 31.33±11.81,which was better than-0·42±19.65 of the control group 2,the treatment group and the control group 1 did not show statistical difference(P=0.829>0.05),but there was statistical difference between control group 1 and control group 2(P<0.001);Comparative analysis of shoulder abduction activity:The difference of shoulder abduction angle of the treatment group was 28.95±14.37,which was better than 8.30±12.75 in the control group 1 and 1.60±11.36 in the control group 2,the difference was statistically significant(P<0.001);Comparative analysis of shoulder adduction activity:The difference of shoulder adduction angle of the treatment group was 21.68±8.18,which was better than 9.15±7.04 in control group 1 and 0.68±1.27 in control group 2,the difference was statistically significant(P<0.001);Visual Analogue Scale(VAS)score comparison:Compared with the data before treatment,the pain index scores of the treatment group and the control group 1 were both reduced.The average reduction of the treatment group was 3.25±3.09 points,which was better than the 0.35±3.63 points of the control group 1 and the control 2 group was-3.27±3.48 points,the difference was statistically significant(P<0.001);Comparison of upper limb function score(DASH questionnaire)before and after treatment in the three groups:the upper limb function score of the patients in the treatment group was 71.78±11.30,better than 36.80±17.18 in control group 2 and-2.35±11.84 in control group 2,the difference was statistically significant P<0.001);Distribution and frequency of tendon nodes:In the 120 patients in this study,the tendon nodes were mainly concentrated in the hand Yangming meridian,and the proportion before treatment was as high as 50%,much higher than other meridians.The single tendon node accounted for the most were Jianyu and Jugu,these two points are subordinate to the Hand Yangming Meridian;Safety evaluation:In this study,all subjects completed the required treatment session of this clinical trial.No obvious infection and bleeding events had been observed;Adverse event observation:There were no adverse reactions such as needle fainting,difficult withdrawal of needles,or broken needles,etc.A total of 5 adverse reactions were reported in the study where 2 participants experienced pain during needle insertion or with needle activity,2 patients reported bruising at the point where the needle was applied,and 1 patient reported slight local inflammation at the treatment site.All reported adverse reactions were recovered within 1 week;Long-term observation:The long-term effect was mainly to observe the recurrence of pain symptoms.Telephone follow-up of 6 months after the end of the treatment course was conducted.In the treatment group,the relapse rate was 20%.In control group 1,the relapse rate was 35%.In control group 2,the relapse rate was 52.5%.The relapse rate of the treatment group was lower than that of the control group,and the long-term efficacy was good.However,there is a possibility of patients to participate in other treatments within these 6 months,which may affect the relapse rate data.Conclusion1.Both sinew acupuncture and conventional acupuncture can improve shoulder joint function in patients with rotator cuff injuries.The short-term therapeutic effects of sinew acupuncture in improving shoulder joint activity(especially abduction,adduction),shoulder pain and upper limb function is superior to conventional acupuncture treatment.2.For rotator cuff injuries,acupuncture points and tendon nodes have certain short-term therapeutic effects on improving shoulder pain,shoulder joint activity,and upper extremity function.It is an efficient and ideal treatment method. |
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