Objective To evaluate the clinical efficacy of combined shock wave therapy and autologous blood-derived bioactive concentrate in treating lower extremity fracture nonunion. Method Fifty-four patients with lower extremity fracture nonunion were randomly assigned to either the study group or the control group. The study group received a combination of shock wave therapy and autologous blood-derived bioactive concentrate treatment,while the control group received extracorporeal shock wave therapy alone. Callus formation was assessed using X-ray scores at 2,3,and 6 months post-treatment. Pain was evaluated using the visual analog scale ( VAS) under weight-bearing conditions. Healing rates,time to weight-bearing,and adverse reactions were compared between groups at the end of treatment to assess clinical efficacy. Result No significant difference in callus X-ray scores was observed between groups at 2 months post-treatment (P>0.05). However,the study group showed significantly higher callus X-ray scores at 3 and 6 months post-treatment ( P<0.05 ).VAS scores were comparable between groups at 2 months ( P>0.05 ) but were significantly lower in the study group at 3 and 6 months post-treatment ( P<0.05 ).The study group demonstrated a higher cure rate ( P<0.05 ) and earlier weight-bearing time ( P<0.05 ) compared to the control group. No significant difference in adverse reactions was noted between groups ( P>0.05 ). Conclusion The combination of shock wave therapy and autologous blood-derived bioactive concentrate injection at the fracture site demonstrates superior efficacy in treating fracture nonunion,enhancing the fracture healing process.