| It is recognized that small needle-knife therapy,one of the external treatments of traditional Chinese medicine(TCM)can improve the range of the hip joint motion in clinical practice,and our previous studies have confirmed its effectiveness in improving the the range of the hip joint motion sufferd from osteonecrosis of the femoral head.However,because the anatomical position of the hip joint is deep and the surrounding muscles are rich,accompanied by anatomical characteristics such as important blood vessels and nerves,the traditional needle-knife therapy has some problems such as difficulty in exact specific position,too large treatment scope,and so on.To solve this,visual small needle-knife platform was developed which consisted of hardware part and software part,and the hardware mainly includes:graphics workstations,sensor interface unit,system control unit,the magnetic field generator,a new type of magnetic positioning needle knife.Based on open source database such as VTK,ITK and Qt etc,software part was composed of data management module,data processing module,navigation module and rendering and displaying module.Measured by simulation experiments,the precision of the visual small needle-knife platform is about 1.77 mm,which can meet the requirements of clinical application.The clinical application of this visual small needle-knife therapy platform to improve the functional disorders of osteonecrosis of the femoral head joint is studied:Objective1 To develop a norm of therapeutic regimen for the treatment of osteonecrosis of the femoral head by visual small needle-knife therapy.2 To evaluate the effectiveness and safety of visual small needle-knife therapy in improving the dysfunction of osteonecrosis of the femoral head.MethodsIn this study,prospective randomized controlled trial design is used,and patients sufferd from osteonecrosis of the femoral head in wangjing hospital of China Academy of Chinese Medical Science are randomly divided into treatment group and control group.Both groups are treated with multi-approach traditional Chinese medicine,such as oral Chinese medicine.In the control group,patients sufferd from osteonecrosis of the femoral head receive traditional small needle-knife therapy.The details are as follows:contractural capsule of the hip is released and dissected by capsule-cutted-small-needle-knife therapy.Adductor tendons are released and dissected by medial-hip-cutted-small-needle-knife therapy.Iliotibial band is released and dissected by lateral-hip-cutted-small-needle-knife therapy.In the treatment group,patients sufferd from osteonecrosis of the femoral head receive visual small needle-knife therapy.The details are as follows:To improve flexion function,lateral part of iliofemoral ligament,gluteal crest of musculus glutaeus maximus,posterior hip articular capsule are released and dissected precisely under the intervention of visual needle-knife in the therapy group.To improve the extension function,rectus femoris,sartorius muscle,anterior gluteal medial muscle,anterior hip articular capsule are released and dissected precisely under the intervention of visual needle-knife.To improve internal rotation function,medial part of iliofemoral ligament,piriformis muscle at the insertion point of great trochanter,The insertion of the femoral ligament,posterior external articular capsule are released and dissected precisely under the intervention of visual needle-knife.To improve the extorsion function,ligament pubocapsulare,musculi tensor fasciae latae,adductors are released and dissected under the intervention of visual needle-knife.To improve adduction function,musculi glutaeus medius and iliotibial band are released and dissected precisely under the intervention of visual needle-knife.To improve abduction function,contractural adductor tendon is released and dissected precisely under the intervention of visual needle knife.According to the requirements of evidence-based medicine,Case report form(CRF)with uniform standards is designed,including general demographic information,hip mobility,VAS,Harris hip score,survival quality scale(SF-36),etc.Two groups of patients are followed up for 1 week,2 weeks,3 months and 6 months.Spss22.0 statistical package is used for statistical processing.Results1 Completion status of clinical trialA total of 200 patients are enrolled and 200 patients are followed up for 1 week.A total of 200 patients are followed up for 2 weeks.A total of 182 patients are followed up for 3 months,including 89 patients in the treatment group,93 of which in the control group,and 18 cases without follow-up time.A total of 150 patients are followed up for 6 months,including 75 patients in the treatment group and 75 in the control group,and 50 patients without follow-up time.2 Baseline descriptionThere is no significant difference between control group and treatment group in the baseline information,such as age,gender,ARCO stage,range of flexion,extension,internal rotation,extorsion,abduction,adduction motion,total score of joint activities,VAS,Harris hip score,various energy(VT),social function(SF),physiological function(PF),mental health(MH),general health(GH),physiological functions(RP),functions of emotion(RE)and body pain(BP)after all the data are analyzed with the SPSS 22.0 software(P>0.05).3 Analysis of overall efficacy before and after treatmentRange of flexion,internal rotation,extorsion,adduction,abduction motion,total score of joint activities,VAS,Harris hip score,mental health(MH),general health(GH)before treatment are 106.33±15.24、16.08±7.03、27.90±7.27、12.45±9.55、21.80±8.55、188.60±28.72、4.59±1.09、64.03±11.30、62.70±15.49、5(20)respectively.Range of flexion,internal rotation,extorsion,abduction,adduction motion.total score of joint activities,VAS,Harris hip score after 1-week treatment are 111.83±14.60、20.18±7.32、30.08±7.85、20.38±9.90、24.63±8.39、211.93±28.74、3.30±1.04、65.85 ± 8.23 respectively.Range of flexion,internal rotation,extorsion,abduction,adduction motion,total score of joint activities,VAS,Harris hip score after 2-week treatment are 112.03±14.36、20.20±7.31、30.58±8.05、20.38±9.90、25.35±8.35、213.53±28.65、3.10±1.02、66.86±8.08 respectively.Range of flexion,internal rotation,extorsion,abduction,adduction motion.total score of joint activities,VAS,Harris hip score,mental health(MH),general health(GH)after 3-month treatment are 111.79±14.81、20.22±7.07、30.55±7.99、20.88±9.51、25.44±8.35、213.82±28.72、2.43±1.20、68.80±8.11、63.98±15.07、10(20).Range of flexion,internal rotation,extorsion,abduction,adduction motion,total score of joint activities,VAS,Harris hip score,mental health(MH),general health(GH)after 6-month treatment are 112.00±14.52、20.67±7.06、30.77±8.02、21.13±9.01、26.00± 8,37、215.63 ±28.97、2.18± 1.24、72.00±7.26、64.53±14.53、10(20)respectively.Range of flexion,internal rotation,extorsion,abduction,adduction motion,total joint activities,Harris scoring index after 1-week treatment,2-week treatment,3-month treatment,6-month treatment are higher than before treatment.VAS after 1-week treatment,2-week treatment,3-month treatment,6-month treatment are lower than before treatment.Mental health and general health of survival quality scale(SF-36)after 3-month treatment,6-month treatment are higher than before treatment,(p<0.05).4 Analysis of efficacy between treatment group and control group.4.1 Comparison of efficacy between treatment group and control group after 1-week treatment.Range of flexion motion in control group and experimental group before treatment are 104.65±15.41 vs 108.00± 14.96 respectively.After 1-week treatment range of flexion are 109.35± 14.92 vs 114.30±13.90 respectively,and there is a significant difference between the two groups after 1-week treatment(P<0.05).Change value of total joint activity score compared with baseline after 1-week treatment in control group and experimental group are 18.65±3.54 vs 28.00± 13.73 respectively,and there is a significant difference between the two groups after 1-week treatment(P<0.05).VAS in control group and experimental group before treatment are 4.50±1.05 vs 4.68±1.11 respectively,and after 1-week treatment VAS are 3.54±0.99 vs 3.07±1.04 respectively.There is a significant difference between the two groups after 1-week treatment(P<0.05).There is no significant difference between groups after 1-week treatment in range of extension,internal rotation,extorsion,abduction,adduction motion,Harris hip score,various energy(VT),social function(SF),physiological function(PF),mental health(MH),general health(GH),physiological functions(RP),functions of emotion(RE)and body pain(BP)(P>0.05).4.2 Comparison of efficacy between treatment group and control group after 2-week treatmentRange of flexion motion in control group and experimental group before treatment are 104.65±15.41 vs108.00± 14.96 respectively.After 2-week treatment range of flexion are 109.40± 14.69 vs 114.65±13.60 respectively,and there is a significant difference between the two groups after 2-week treatment(P<0.05).Change value of total joint activity score compared with baseline after 2-week treatment in control group and experimental group are 20.00±6.51 vs 29.65±13.66 respectively,and there is a significant difference between the two groups after 2-week treatment(P<0.05).VAS in control group and experimental group before treatment are 4.50±1.05 vs 4.68±1.11 respectively.After 2-week treatment VAS are 3.31 ±1.01 vs 2.90 ± 1.00 respectively,and there is a significant difference between the two groups after 2-week treatment(P<0.05).There is no significant difference between groups after 2-week treatment in range of extension,internal rotation,extorsion,abduction,adduction motion,Harris hip score,various energy(VT),social function(SF),physiological function(PF),mental health(MH),general health(GH),physiological functions(RP),functions of emotion(RE)and body pain(BP)(P>0.05).4.3 Comparison of efficacy between treatment group and control group after 3-month treatmentRange of flexion in control group and experimental group before treatment are 104.65 ± 15.41vs108.00 ± 14.96 respectively.After 3-month treatment range of flexion are 108.31 ±14.60 vs 114.55±14.29 respectively,and there is a significant difference between the two groups after 3-month treatment(P<0.05).Change value of total joint activity score compared with baseline after 3-month treatment in control group and experimental group are 18.82±9.17 vs 31.57±13.33 respectively,and there is a significant difference between the two groups after 3-month treatment(P<0.05).Harris hip score in control group and experimental group before treatment are 65.40±12.22 vs 62.65 ± 10.17 respectively.After 3-month treatment Harris hip score are 67.67 ± 7.53 vs 69.92 ±8.55 respectively,and there is a significant difference between the two groups after 3-month treatment(P<0.05).There is no significant difference between groups after 3-month treatment in range of extension,internal rotation,extorsion,abduction,adduction motion,VAS,various energy(VT),social function(SF),physiological function(PF),mental health(MH),general health(GH),physiological functions(RP),functions of emotion(RE)and body pain(BP)(P>0.05).4.4 Comparison of efficacy between treatment group and control group after 6-month treatmentRange of flexion motion in control group and experimental group before treatment are 104.65±15.41vs108.00±14.96 respectively.After 6-month treatment range of flexion are 109.07±14.40 vs 114.93±14.13 respectively,and there is a significant difference between the two groups after6-month treatment(P<0.05).Change value of total joint activity score compared with baseline after 6-month treatment in control group and experimental group are 23.07±12.08 vs 33.93 ± 15.19 respectively,and there is a significant difference between the two groups after 6-month treatment(P<0.05).Harris hip score in control group and experimental group before treatment are 65.40±12.22 vs 62.65±10.17 respectively.After 6-month treatment Harris hip score are 70.87±8.02 vs 73.15±6.27 respectively,and there is a significant difference between the two groups after 6-month treatment(P<0.05).There is no significant difference between groups after 6-month treatment in range of extension,internal rotation,extorsion,abduction,adduction motion,VAS,various energy(VT),social function(SF),physiological function(PF),mental health(MH),general health(GH),physiological functions(RP),functions of emotion(RE)and body pain(BP)(P>0.05).5 Security related resultsThere are no adverse reactions such as fainting on small needle-knife therapy,broken needle or postoperative infection in both groups.Conclusion1 The visual needle-knife treatment platform used to improve the function of osteonecrosis of the femoral head is simple,feasible and accurate which can be used in clinical application.2 For the patients with limited function of osteonecrosis of the femoral head,both traditional and visual needle-knife can improve the motion of the joint,which suggests that the needle-knife is one of the important methods for the treatment of osteonecrosis of the femoral head.3 The visual needle-knife has more advantages than the traditional method in the improvement of flexion,total hip motion score and Harris hip score,which indicates that the visual needle-knife is accurate in anatomical orientation and standardized operation,and can improve the curative effect of improving the joint function of patients sufferd from osteonecrosis of the femoral head. |
PDF Full Text Request