| Background and purpose:Osteoarthritis is a common disease in the elderly population, as well as one of the most common joint degenerative diseases in the world. Knee osteoarthritis(KOA)is the most common type of osteoarthritis. In recent years, many researches on the treatment of KOA were reported. There exist certain diversities of therapeutic effects among the different treatments and each various treatment has its application scope,advantages and disadvantages. The treatments of KOA shows a diverse,multidisciplinary, comprehensive directions, but the non operative treatment is still the main method for the treatment of patients with mild or moderate KOA whose joint deformation and joint cavity lesions are less. Intra-articular injection of sodium hyaluronate is the treatment that has been often studied, while some researchers questioned its reliability and safety. Meanwhile, ideal therapeutic effect is often difficult to achieve by the single intra-articular injection of sodium hyaluronate.Extracorporeal shock wave therapy(ESWT) and intra-articular injection of ozone are the local physical treatments with high security used in the department of orthopedics in the recent years and have good prospects. No studies of the combination of these two treatments with intra-articular injection of sodium hyaluronate were reported.Based on the above situation, this study evaluated and compared the therapeutic effects and safety of the three treatments including single ESWT, combination of intra-articular injection of sodium hyaluronate with ozone therapy, combination of ESWT and intra-articular injection of sodium hyaluronate with ozone therapy to provide objective basis for the long-term effective, safe treatment for KOA.Methods:180 cases of KOA patients hospitalized in the Department of Pain at the Hospital of Jilin Provincial Hospital from February of 2015 to February of 2016 were selected as research subjects. The patients were randomly divided into group A,group B, group C. Respectively 60 cases were included into each group. The treatments of the three groups were as follows. The patients from group A were treated with single ESWT treatment. The treatment frequency was set for 15.0Hz.Impact point number at 90°of the ipsilateral knee bent was 3000. According to the tolerance of patients, shock wave energy gradually increased to the maximum tolerated energy from 1.5BAR. The treatment was once per week, the whole treatment included 4 times. The patients from group B were treated with intra-articular injection therapy of medical ozone combined with sodium hyaluronate.20 m L medical ozone was firstly injected after the effusion of joint cavity aspiration,then 25 m L sodium hyaluronate was intra-articular injected on the second day. This treatment was once per week, the whole treatment included 4 times. The patients from group C were treated with ESWT combined with intra-articular injection therapy medical ozone and sodium hyaluronate. The application methods were as same as the other two groups. This treatment was once per week, the whole treatment included 4 times.The following indicators of the three groups were evaluated and compared:1, Pain degree evaluation: the Visual Analogue Scale(VAS) scores were employed to evaluate the degrees of pain in the patients from three groups before treatment, at 2nd week of treatment, at 4th week of treatment, at 3rd month after treatment.2, Knee function evaluation: Lysholm knee scores were employed to evaluate the knee joint function of the patients from three groups before treatment, at 2nd week of treatment, at 4th week of treatment, at 3rd month after treatment. Knee Injury and Osteoarthritis Outcome Score(KOOS) scale was employed to evaluate the knee joint function of the patients in the three groups before treatment, at 2nd week of treatment, at 4th week of treatment, at 3rd month after treatment3. Clinical efficacy evaluation: According to "diagnostic criteria of TCM syndrome" by the Ministry of Health, the clinical therapeutic effects were evaluated at 3rd month of the treatment. Meanwhile, the total efficiency was calculated.4, Safety evaluation: the gastrointestinal adverse reactions, the cardiovascular adverse reactions, the neurological adverse reactions, the local adverse reactions of patients from the three groups during the treatment were observed and compared.Statistical methods: the statistical software package of SPSS 18 was used for statistical analysis. The variances between groups at different time points were compared by repeated measurement variance analysis. The variances between groups at same time point were multivariate linear model analysis or one-way variance analysis. The distribution of the therapeutic effects was compared by the rank test for multi group data(Kruskal-Wallis H method). The clinical effective rates and the incidences of adverse reactions were compared by Chi-square test. ?=0.05 was taken as the test level.Result:1 There were no statistical differences in ages, sex composition, BMI, K-L classification among the patients from three groups(P>0.05).2 There were statistical differences in time effects, group effects and time*group interaction effects of VAS scores at each time points before and after the treatment among the patients from three groups(P<0.05); there were no statistically significant differences of VAS scores before the treatment among the patients from three groups(P>0.05). There were statistical differences at 2nd week, 4th week of the treatment and 3rdmonth after the treatment(P<0.05), the VAS scores of the patients in group C were lower than those of group A or group B. There were statistical differences at 4thweek of the treatment and 3rdmonth after the treatment, and the VAS scores of the patients in the group A were lower than those in the group B(P<0.05).3 There were statistical differences in time effects, group effects and time*group interaction effects of Lysholm knee scores at each time points before and after the treatment among the patients from three groups(P<0.05); there were no statistically significant differences in Lysholm knee scores before the treatment among the patients from three groups(P>0.05). At 2nd week, 4th week of the treatment and 3rd month after the treatment, the difference were statistically significant(P<0.05), the Lysholm knee scores of the patients in group C were higher than those of group A or group B. At 4th week of the treatment and 3rd month afterthe treatment, the Lysholm knee scores of the patients in the group A were higher than those in the group B, and the differences were statistically significant(P<0.05).4 There were statistical differences in time effects, group effects and time*group interaction effects of scores at dimensions of symptoms, motor function,quality of life in KOOS scale at each time points before and after the treatment among the patients from three groups(P<0.05). There were statistical differences in time effects and time *group interaction effects of score at dimension of daily living ability in KOOS scale at each time points before and after the treatment among the patients from three groups(P<0.05), while the group effects were not significant(P>0.05). There were no statistically significant differences of scores at all dimensions in KOOS scale before the treatment among the patients from three groups(P>0.05). There were statistical differences at 2ndweek, 4thweek of the treatment and 3rd month after the treatment in scores at dimensions of symptoms,motor function, quality of life in KOOS scale(P<0.05). The scores at the above four dimensions of the patients in group C were higher than those of group A, those in group A were higher than those of group B, the differences were statistically significant(P<0.05). At 2nd week of the treatment, the differences of the scores at dimension of daily living ability in KOOS scale between the patients in the three groups were not statistically significant(P>0.05) while the differences at 4th week of the treatment and 3rdmonth after the treatment were statistically significant(P>0.05).The score at dimension of daily living ability in KOOS scale of the patients in group C was higher than that in group A, that in group A was higher than that in group B,the differences were statistically significant(P<0.05).5 The differences of distribution of therapeutic effects and clinical efficiency between the patients in the three groups were statistically significant(P<0.05). The clinical efficiency of the patients in group C was significantly higher than that in group A or group B, the difference was statistically significant(P<0.05), while the difference of the clinical efficiency between the patient in group A and group B was not statistically significant(P>0.05).6 The difference of the incidence of adverse reactions among three groups was not statistically significant(P>0.05).Conclusions:In the clinical treatment of KOA, both ESWT or intra-articular injection of sodium hyaluronate combined with medical ozone can alleviate the pain symptoms,improve joint function, increase the quality of life and the activities of daily living,and has a relatively high safety. When the combination of ESWT and intra-articular injection of sodium hyaluronate and medical ozone were employed, better effects can be achieved, with no increase of adverse effects. The clinicians should give a reasonable choice according to the individual conditions of the patient when the treatment plan was set, but also pay attention to the safety and standard treatment. |
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