Objective To evaluate the clinical efficacy of Gushang External Wash Granules combined with extracorporeal shockwave therapy(ESWT)in treating early-to-middle-stage knee osteoarthritis(KOA)with cold-damp obstruction syndrome.Methods A total of 84 patients diagnosed as early-to-middle-stage KOA(cold-damp obstruction syndrome)at the Orthopedic Outpatient Clinic of Dongguan Hospital of Guangzhou University of Chinese Medicine(Dongguan Traditional Chinese Medicine Hospital)from July 2022 to July 2023 were enrolled.Patients were randomly assigned to either the observation group or control group using a random number table,with 42 cases in each group.Both groups received ESWT,while the observation group additionally underwent topical washing with Gushang External Wash Granules.The treatment course lasted 4 weeks for both groups.The changes in traditional Chinese medicine(TCM)syndrome scores,Visual Analogue Scale(VAS)scores for pain,and Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)scores in the two groups were measured before and after treatment,and the clinical efficacy was evaluated after treatment.Results(1)After 4 weeks of treatment,the total effective rate was 95.24%(40/42)in the observation group versus 76.19%(32/42)in the control group.Intergroup comparison(tested by chi-square test)showed significantly superior efficacy in the observation group(P＜0.05).(2)After treatment,both groups demonstrated significant reductions in VAS pain scores compared to those before treatment(P＜0.01),while no statistically significant difference was found between groups(P＞0.05).(3)WOMAC scores were decreased significantly in both groups after treatment(P＜0.01),and the observation group showed significantly greater reduction than the control group(P＜0.01),with statistically significance.(4)After treatment,the scores for the TCM symptoms of intolerance of cold and limb chilling,restricted flexion-extension,and stiffness and numbness in the extremities were significantly reduced in both groups(P＜0.01),and the observation group demonstrated significantly greater improvements in all TCM syndrome scores than the control group(P＜0.01).Conclusion The combination of Gushang External Wash Granules and ESWT demonstrates significant efficacy for the patients with early-to-middle-stage KOA of cold-damp obstruction type,and is effective on alleviating clinical symptoms and improving knee function and quality of life of the patients.