| Objective1.Comparing and analyzing the mass(E),size(area,thickness)and function(percentage change of muscle thickness)of lumbar multifidus muscle in patients with ankylosing spondylitis and healthy volunteers,to explore the relationship and characteristics of ankylosing spondylitis multifidus muscle,sacroiliac joint blood flow and the progression of the disease.2.Designing a randomized controlled clinical trial to evaluate the clinical efficacy and safety of acupuncture in the treatment of ankylosing spondylitis by setting up acupuncture group and placebo acupuncture group.3.To observe the changes of the shape,function and quality of multifidus muscle before and after acupuncture intervention,and to explore the potential physiological mechanism of acupuncture on ankylosing spondylitis from the perspective of repairing multifidus muscle.MethodsStudy 1:Ultrasonographic characteristics of multifidus muscle and sacroiliac joint blood flow in ankylosing spondylitisThirty qualified patients with axial ankylosing spondylitis and 27 matched healthy volunteers were recruited in Guangdong Provincial Hospital of Traditional Chinese Medicine.Without intervention,Superb Microvascular Imaging(SMI),shear-wave elastography(S WE)and two-dimensional ultrasound were used to observe the lumbar multifidus muscle and sacroiliac joint at the L4/5 level of the two groups of subjects.Evaluation indicators:①Mass of multifidus muscle:Young’s modulus E of multifidus muscle at lumbar L4/5 level;②The size of multifidus muscle:the area and thickness of the multifidus muscle in the contractile and diastolic state at the lumbar L4/5 level;③Function of multifidus:the percentage change of multifidus thickness at lumbar L4/5 level;④blood flow grading in the sacroiliac joint region;⑤Sacroiliac joint area.Study 2:Clinical effect of acupuncture on ankylosing spondylitisPatients with axial ankylosing spondylitis were recruited in Guangdong Provincial Hospital of Traditional Chinese Medicine.SPSS 18.0 statistical software package was used to generate random numbers and randomly divided the qualified subjects into the acupuncture group and the non-acupoint shallow acupuncture group in a 1:1 ratio.1.Intervention grouping(1)Acupuncture groupAcupoint selection:the main point:Ganshu(bilateral),Shenshu(bilateral),Pangguang shu(bilateral),Yanglingquan(bilateral),Jizhong,Jinsuo;Acupoint:“Shenxu Duhan" plus Mingmen,"Shenxu Shire"plus Quchi(bilateral),Yinlingquan(bilateral);Acupoints selection referd to the chapter of "low back pain and fasciitis" in<Acupuncture Science>,the textbook of the 12th Five-Year Plan edited by Liang Fengsheng and Zhao Jiping,Ministry of Health.The Acupoints localization referd to the 2006 national standard of the People’s Republic of China(GB/T12346-2006),<Name and Location of Acupoints>.Operation:In prone position,skin at acupoints and hands of the surgeon were routinely disinfected.After positioning the acupoints with pressing-hand,inserted the needle into the acupoints,Ganshu,Shenshu,Jizhong,Jinsuo with 0.30×25mm needle into about 15mm,Yanglingquan with 0.30×40mm needle into about 25mm.Shenshu and Ganshu were connected with electrodes.The same electrode connection should not go through the heart.Electroacupuncture parameters:density wave,10/50Hz,current intensity of acupuncture group 1mA～5mA.Keep the needle for 20 to 30 minutes each time.(2)Non-acupoint shallow acupuncture groupAcupoint selection:The non-meridian non-point of Shenshu,Ganshu,Pangguangshu was located horizontally 1cm away from acupoints.Yanglingquan was horizontally I cm back,Jizhong,Jinsuo was 1cm to the right horizontally.Mingmen,Yaoyangguan,Quchi was located horizontally 1cm away from acupoints,Yanglingquan was horizontally 1cm back.Operation:In prone position,skin at acupoints and hands of the surgeon were routinely disinfected.After positioning the acupoints with pressing-hand,pierce 2～3mm with 0.25 ×25mm flim-needle,no manipulation,do not require needle feeling.The current intensity of electroacupuncture was 0.1mA～0.3mA to the patient’s conscious comfort.Keep the needle for 20～30min each time.2.The period of treatmentThe total course of treatment was 12 weeks,2～3 times a week,each time interval of 1～2 days,80%of the completion of treatment for effective cases.3.Evaluation time points and indicatorsThe clinical efficacy and safety of acupuncture in patients with ankylosing spondylitis were analyzed and evaluated at the 0,6 and 12 weeks.Main Outcomes:Ankylosing Spondylitis Quality of Life Assessment Scale(ASQOL),BATH Ankylosing Spondylitis Measurement Index(BASMI)Secondary outcome:Bath ankylosing spondylitis functional index(BASFI),Bath ankylosing spondylitis disease activity index(BASDAI),Keitel functional test,VAS score and fatigue scale FS-14 were evaluated.SAS and SDS scales were evaluated at week 0 and week 12.Study 3:Study on repairing multifidus muscle of ankylosing spondylitis by acupuncturePatients with axial ankylosing spondylitis were recruited in Guangdong Provincial Hospital of Traditional Chinese Medicine.SPSS18.0 statistical software package was used to generate random numbers and randomly divided the qualified subjects into the acupuncture group and the non-acupoint shallow acupuncture group in a 1:1 ratio.1.The intervention plan and course of treatment were the same with study 2.2.Evaluation indicators(1)Mass of multifidus:Young’s modulus E of multifidus at lumbar L4/5 level;(2)Size of multifidus muscle:CSA and thickness of multifidus muscle before and after contraction at lumbar L4/5 level;(3)Function of multifidus muscle:percentage change in thickness;(4)Regional blood flow grading of the sacroiliac joint.3.Timing of evaluatio:0w,12w of acupuncture interventionSPSS18.0 statistical software was used for data analysis.Measurement data were in line with normal distribution and homogeneity of variance was expressed as mean ± standard deviation(x ± s),while those were not in line with normal distribution were expressed as median(quaternary interval).The t test of two independent samples(or Mann-Whitney U test)was used for comparison between groups,and the paired t test(or Wilcoxon signed rank test)was used for comparison before and after treatment.Enumerative data were represented by constituent ratio and rate,and the chi-square test or Fisher’s exact test were used.Correlation analysis was performed by Pearson correlation analysis or Spearman correlation coefficient analysis according to data types.Two-sided test was used for statistical test,and the significance level of difference was α=0.05.P<0.05 indicated that the difference was statistically significant.ResultsStudy 11.General demographic data:30 AS patients and 27 healthy volunteers were included in the trial.Baseline data of the two groups showed no statistical difference in height,weight and gender,and were comparable.2.Morphology and function of multifidus muscle(1)Mass of multifidus muscleYoung’s modulus E of L4/5 multifidus muscle in the left and right waist of patients with ankylosing spondylitis was significantly higher than that of healthy people(P<0.05).(2)Size of multifidus muscleArea:The area of multifidus muscle at the left and right lumbar L4/5 level in relaxed state was smaller in AS patients than in healthy volunteers.There was statistically significant difference between the two groups on the right side(P<0.05),while there was no statistically significant difference on the left side(P>0.05).The area of multifidus muscle at the left and right lumbar L4/5 level was smaller in AS patients than in healthy volunteers,and the difference between the two groups was statistically significant(P<0.05).The difference in contractile and diastolic area of multifidus muscle at L4/5 level on left and right sides was smaller than that in healthy volunteers,and the difference was statistically significant(P<0.05).Thickness:There was no statistical difference in the thickness of multifidus muscle at the left and right lumbar L4/5 level between AS patients and healthy volunteers in relaxed state(P>0.05).The left and right multifidus muscle thickness of AS patients was smaller than that of healthy volunteers under contractile state,and the difference on the left side was statistically significant(P<0.05),while the difference on the right side was not statistically significant(P>0.05).The systolic-diastolic thickness difference of left and right multifidus muscles in AS patients was smaller than that in healthy volunteers,and the difference on the left side was statistically significant(P<0.05),while the difference on the right side was not statistically significant(P>0.05).(3)multifidus muscle functionThe percentage of thickness change in AS patients on the left and right sides was smaller than that in healthy volunteers,and the difference on the left side was statistically significant(P<0.05),while the difference on the right side was not statistically significant(P>0.05).3.Blood flow in the sacroiliac jointThere was statistically significant difference between the left and right sacroiliac joint blood flow grading of AS patients and healthy volunteers(P<0.05).On the left side of AS patients,the proportions of grade 0,1 and 2 blood flow were 30%,50%and 20%,respectively;on the right side,the proportions of grade 0,1 and 2 blood flow were 36.7%,46.7%and 16.6%,respectively.The left and right blood flow of healthy volunteers was graded 0,and no obvious abnormal blood flow signals were observed.4.Sacroiliac joint areaThe results of the sacroiliac joint area showed that the AS patients were smaller than the healthy volunteers,but there was no statistical difference(P>0.05).5.Correlation analysis resultsThere was no correlation between blood flow grade and Young’s modulus E,CSA of multifidus,thickness of multifidus and percentage of multifidus thickness change(P>0.05).Young’s modulus E of lumbar multifidus was negatively correlated with CSA difference of left and right lumbar multifidus(P<0.05).The right Young’s modulus E was negatively correlated with the thickness difference of the right multifidus muscle(P<0.05).The CSA difference of left and right muscles was positively correlated with the thickness difference and percentage change of multifidus muscle on left and right sides(P<0.001).Study 21.General data:22 cases were eventually included in the acupuncture group and 18 cases in the non-acupoint shallow acupuncture group.There was no statistical significance in age.sex,height,weight,education background.course of disease,disease activity,CRP elevation or basic medication between the two groups(P>0.05).2.The main indicators total VAS,BASMI analysis resultsThe total VAS score at week 6 was lower than that at week 0,but the difference was not statistically significant(P>0.05).The score at week 12 was lower than that at week 0,and the difference was statistically significant(P<0.05).The difference between week 6 and week 12 was not statistically significant(P>0.05).The score of BASMI scale at week 6 was lower than that at week 0,but the difference was not statistically significant(P<0.05).The score at week 12 was significantly lower than that at week 0,and the difference was statistically significant(P<0.05).There was no significant difference in VAS and BASMI score between the two groups before and after treatment(P>0.05).3.Analysis results of secondary indicatorsThe scores of BASDAI at week 6 were lower than those at week 0 but the difference was not statistically significant(P>0.05);the scores at week 12 were significantly lower than those at week 0,with a statistically significant difference(P<0.05);the scores at week 12 were lower than those at week 6.with a statistically significant difference(P<0.05).There was no statistically significant difference on BASDAI between groups at each time point(P>0.05).The scores of BASFI at week 6 and 12 were lower than those at week 0,but the difference was not statistically significant(P>0.05).The BASFI scores were no statistically significant difference between groups at each time point(P>0.05).There was no statistical difference in the change of Keitel scores between the two groups,and the scores of both groups decreased gradually with the progress of treatment,the scores of week 6 was lower than that of week 0 but the difference was not statistically significant(P>0.05);the scores of week 12 was lower than that of week 0 with statistical difference(P<0.05);the score of week 6 was not statistically different from that of week 12(P>0.05).There was no significant difference on Keitel between the two groups at any time point(P>0.05).The score of ASQOL scale in the 6th week of acupuncture intervention was lower than that in the 0th week of intervention,and the difference was statistically significant(P<0.05),The score in the 12th week was lower than that in the 0th week of intervention.and the difference was statistically significant(P<0.05).The score between the 6th week and the 12th week tended to be stable,and the difference was not statistically significant(P>0.05).There was no significant difference in ASQOL scores between the two scales before and after treatment(P>0.05).The FS-14 score of the two groups decreased gradually with the progress of treatment.At week 6.the score was lower than that at week 0 but the difference was not statistically significant(P>0.05).At week 12,the score was lower than that at week 0 and the difference was statistically significant(P<0.05).There was no statistically significant difference between groups at each time point(P>0.05).The total back pain VAS score at week 6 was lower than that at week 0,but the difference was not statistically significant(P>0.05).The VAS score at week 12 was significantly lower than that at week 0,and the difference was statistically significant(P<0.05).The VAS score at week 6 and 12 was not statistically significant(P>0.05).There was a statistically significant difference in VAS scores between week 6 and week 0(P<0.05),and there was no statistically significant difference in VAS scores between week 6 and week 12(P>0.05).There was no statistical significance in total VAS,total back pain VAS and night back pain VAS three time points between the groups(P>0.05).There was no statistical significance in the changes of SAS and SDS before and after treatment(P>0.05),and there was no statistical significance in the differences between groups before and after treatment(P>0.05).4.Correlation analysis:(1)CSA correlation analysis of multifidus muscleThe systolic-diastolic difference of right CSA was negatively correlated with Keitel score of functional activity and total VAS score at baseline(P<0.05).There was no correlation with other baseline scale scores(P>0.05).(2)Correlation analysis of multifidus muscle thicknessThere was no correlation between the difference of left multifidus thickness and the percentage of thickness change and the scoring indexes of each scale(P>0.05).The thickness difference and percentage change of the right multifidus muscle were negatively correlated with the total VAS(P<0.05),but had no correlation with other baseline scale scores(P>0.05).(3)Correlation analysis of Young’s modulus value EYoung’s modulus on the right side E was positively correlated with BASFI,BASMI,KEITEL and total VAS(P<0.05).The left Young’s modulus E was positively correlated with Keitel and total VAS(P<0.05),but had no correlation with BASFI and BASMI(P>0.05).There was no correlation between Young’s modulus E and ASQOL,BASDAI,total back pain VAS and night back pain VAS(P>0.05).(4)Correlation analysis of blood flow grading in the sacroiliac jointThere was no correlation between sacroiliac joint blood flow grade and active stage of ankylost spondylitis or elevated levels of CRP inflammatory factors(P>0.05).There was no correlation between blood flow grade and baseline ASQOL,BASFI,BASDAI,BASMI,KEITEL,total VAS,total back pain VAS,and night back pain VAS(P>0.05).5.Safety analysis:No acupuncture-related adverse reactions occurred in the recruited subjects during the trial.Study 31.Multifidus muscle massIntergroup analysis:There was no statistical difference between the left and right sides before treatment(P>0.05),and there was comparability between the groups.After treatment,E value of acupuncture group was lower than that of control group,but there was no statistical difference between left and right groups(P>0.05).Intra-group analysis:E values of left and right multifidus muscles in the acupuncture group were decreased after treatment compared with before treatment,the difference was statistically significant(P<0.05),while there was no statistically significant difference in E values of left and right multifidus muscles in the control group before and after treatment(P>0.05).2.Multifidus muscle size(1)CSA analysis of multifidus muscleCSA diastole:There was no significant difference between the left and right sides before and after treatment(P>0.05).There was no significant difference between the two groups before and after treatment(P>0.05).The CSA contractile and contractile diastolic differences of the right multifidus muscle were not comparable between the two groups before treatment(P<0.05),and only the CSA data of the left multifidus muscle were statistically analyzed.CSA contraction:There was no statistical difference between the left multifidus muscle before and after CSA treatment(P>0.05).There was no statistical difference between the two groups(P>0.05),and there was no statistical difference between the two groups before and after treatment(P>0.05).The CSA difference of multifidus contractile and diastolic:there was no significant difference between the two groups before and after treatment(P>0.05).There was no significant difference between groups before and after treatment(P>0.05).(2)Thickness analysis of multifidus muscleThickness difference:There was no significant difference between the two groups before and after left and right side treatment(P>0.05).The thickness difference of left multifidus muscle in the acupuncture group increased statistically after treatment compared with before treatment(P<0.05),while there was no statistically significant difference between the left and right groups of the control group before and after treatment(P>0.05).3.Multifidus muscle functionPercentage change of thickness:the comparison between the groups after treatment on the left side of the acupuncture group was higher than the control group,the difference was statistically significant(P<0.05),there was no statistical difference between the two groups before and after treatment on the right side(P>0.05).The percentage of thickness change of left multifidus muscle in the acupuncture group increased significantly after treatment compared with before treatment(P<0.05),while there was no significant difference in the left control group before and after treatment(P>0.05).There was no significant difference in right multifidus muscle between the two groups before and after treatment(P>0.05).4.Intergroup analysis of blood flow gradingIntergroup analysis:There was no statistical difference between the left and right sides before and after treatment(P>0.05).Intra-group analysis:blood flow grading of bilateral sacroiliac joints in the left and right groups was significantly improved before and after treatment,and the difference was statistically significant(P<0.05).Coclusion1.The mass(E),size(area,thickness)and function(percentage change of thickness)of lumbar multifidus muscle in patients with ankylosing spondylitis were lower than those in healthy volunteers.The blood flow signal of the sacroiliac joint in patients with ankylosing spondylitis was different from that in healthy people.The blood flow signal of the sacroiliac joint in healthy volunteers was almost no or less,while the blood flow signal of AS patients was mostly grade 1 or grade 2.There was no significant difference between the sacroiliac joint area and healthy people.2.Acupuncture might improve the quality of life of ankylosing spondylitis,improve the range of motion of the joint,and improve the symptoms of fatigue and pain at night.Acupuncture has clinical efficacy and safety in the treatment of ankylosing spondylitis,and can be used as a complementary and alternative therapy in clinical promotion.3.The improvement of acupuncture on the functional mobility and pain of patients with ankylosing spondylitis might be related to the benign regulation of the quality,thickness and function of multifidus muscle,the promotion of the repair of the shape and function of multifidus muscle,and the improvement of microblood flow in the sacroiliac joint. |
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