目的·观察低强度脉冲聚焦超声（focused low-intensity pulsed ultrasound，FLIPUS）治疗膝骨关节炎(knee osteoarthritis，KOA)的安全性和有效性。方法·纳入重庆医科大学附属第二医院康复医学科2018年8月—2019年8月KOA患者100例，随机分为A组和B组，每组50例。A组接受FLIPUS治疗，B组接受口服双氯芬酸钠缓释片治疗。治疗前，治疗第3日、第6日和第10日采用视觉模拟评分法(visual analogue scale，VAS)评价膝关节疼痛程度，西安大略和麦克马斯特大学骨关节炎调查量表（Western Ontario McMaster Universities Osteoarthritis Index，WOMAC）评价受累膝关节结构及功能，勒凯纳指数（Lequesne index，LI）评价受累膝关节病情严重程度；治疗前、治疗第10日采用膝关节活动度（knee range of motion，KROM）评价膝关节活动范围，最大步行速度(maximum walking speed，MWS)评价患者步行功能。结果·治疗前A组和B组各项膝关节评价指标差异均无统计学意义（均P>0.05）。A组在治疗第6日、第10日VAS、WOMAC评分优于B组（P=0.021，P=0.000；P=0.005，P=0.001）。A组在治疗第10日的LI评分优于B组（P=0.000）。A组在治疗第10日的MWS大于B组（P=0.006），但2组间KROM差异无统计学意义（P=0.064）。结论·FLIPUS可缓解疼痛，改善KOA患者的膝关节结功能，在KOA的治疗中安全性和有效性良好。

Objective · To investigate the safety and efficacy of focused low-intensity pulsed ultrasound (FLIPUS) therapy on the patients with knee osteoarthritis (KOA). Methods · A total of 100 subjects with KOA from August 2018 to August 2019 in the Department of Rehabilitation Medicine at the Second Affiliated Hospital of Chongqing Medical University were sequentially randomized into group A and group B. Among them, FLIPUS was adopted to treat the 50 patients in group A, and the diclofenac sodium was adopted to treat the other 50 patients in group B. Visual analogue scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne index (LI) were used to evaluate knee joint pain, the structure and function of the affected knee joint, and the severity of the affected knee joint at baseline, on day 3, day 6 and day 10 after treatment respectively. The knee range of motion (KROM) and maximum walking speed (MWS) were used to evaluate the knee joint movement and walking function at baseline and on day 10 after treatment respectively. Results · There were on significant differences between two groups with respect to KOA evaluation indexes (P>0.05). Compared with those in group B, patients in group A showed significant improvements in VAS and WOMAC scores on day 6 and day 10 after treatment (P=0.021, P=0.000; P=0.005, P=0.001). Meanwhile, patients in group A had higher LI scores than those in group B on day 10 after treatment (P=0.000). In addition, patients in group A showed significant improvements in MWS (P=0.006) and non-significant improvements in KROM (P=0.064) on day 10 after treatment. Conclusion · FLIPUS is a safe and effective treatment modality for relieving pain and improving the functions of patients with KOA.