通络治痹方联合经筋手法治疗肝肾亏虚、痰瘀互结证早中期膝骨关节炎的随机对照研究OA

Objective:To explore the clinical efficacy of the Tongluo Zhibi formula combined with Jingjin manipulation in the treatment of early and middle-stage knee osteoarthritis(KOA).Methods:From January 2025 to October 2025,152 pa-tients with unilateral KOA were randomly assigned to either a control group or observation group,with 76 patients in each group.Among them,10 cases dropped out from the control group and 6 cases from the observation group.The control group comprised 66 participants,including 27 males and 39 females;34 cases involved the left knee and 32 the right knee;aged 40 to 75 years old,with an average age of(59.87±10.28)years old;disease duration of 8 to 35 months,with an average of(19.59±7.31)months;X-ray K-L grades were 0 in 12 cases,grade Ⅰ in 30 cases,grade Ⅱ in 15 cases,and grade Ⅲ in 9 cases.They were treated with oral celecoxib and glucosamine combined with physical therapy.The observa-tion group had 70 cases,including 26 males and 44 females;34 cases on the left and 36 cases on the right;aged 40 to 75 years old,with an average age of(59.44±9.23)years old;disease duration of 8 to 42 months,with an average of(19.61±7.53)months;X-ray K-L grades were 0 in 15 cases,grade Ⅰ in 36 cases,grade Ⅱ in 12 cases,and grade Ⅲ in 7 cases.They were treated with the Tongluo Zhibi formula combined with Jingjin manipulation therapy.The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)scores,Timed Up and Go(TUG)test,gait parame-ters(step length,step speed,double support phase),muscle tension of the quadriceps and gastrocnemius on the affected side,and the Short Form 36 Health Survey(SF-36)scores were compared before and after treatment in both groups.Safe-ty and adverse events were also evaluated.Results:Both the observation group and the control group showed significant improvements in WOMAC scores for pain,stiffness,joint function,and total scores,compared to before treatment(P<0.05),and the observation group had more significant improvements(P<0.05).After treatment,both groups showed significant improvements in TUG test,step length,step speed,and double support phase(P<0.05).The observation group had better improvements than the control group in the TUG test,step length,and double support phase(P<0.05),whereas no significant difference was observed in gait speed(P>0.05).Before treatment,there were no statisti-cally significant differences in the displacement values of muscle tension of the quadriceps and gastrocnemius on the affect-ed side and SF-36 scores between the two groups(P>0.05).After treatment,both groups showed significant improve-ments in the displacement values of muscle tension of the quadriceps and gastrocnemius on the affected side and SF-36 scores compared to before treatment(P<0.05);however,the observation group had more significant improvements than the control group(P<0.05).No serious adverse events occurred in either group,and the safety was good.Conclusion:The Tongluo Zhibi formula combined with Jingjin manipulation can effectively improve the clinical symptoms of early and middle-stage KOA patients,improve the muscle tension of the affected lower extremity,enhance the patients'walking ability,and thereby im-prove their quality of life,with good safety.