BACKGROUND:Smal-needle-knife therapy for knee osteoarthritis has no uniform location, operation and mechanisms of action. Studies have proved that exercise therapy can enhance muscle strength, increase stability of the knee, improve joint range of motion, and effectively relieve pain. OBJECTIVE:To observe the clinical effect of smal-needle-knife therapy combined with exercise therapy for treatment of knee osteoarthritisvia a randomized controled clinical trial. METHODS:122 patients were randomly divided into treatment group (n=61; smal-needle-knife therapy combined with exercise therapy) and control group (n=61; low-frequency therapy combined with exercise therapy). Then, clinical efficacy in the two groups were assessed by statistical analysis of visual analog scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sweling degree of the knee joint, quadriceps circumference, flexion and extension of the knee joint before and after treatment. Meanwhile, adverse reactions in patients were recorded for safety evaluation. RESULTS AND CONCLUSION:(1) The visual analog scale and WOMAC scores in the two groups were both significantly improved at 2 weeks after treatment (P < 0.05). Moreover, these scores in the treatment group were significantly lower than those in the control group (P < 0.05). (2) At 12 weeks after treatment, the WOMAC score in the treatment group was better than that in the control group (P< 0.05), and the range of motion of the knee joint was also better in the treatment group than the control group (P< 0.05). (3) According to the full analysis set and per protocol set, the total efficiency rats in the treatment group were both superior to those in the control group (P< 0.001). (4) In the treatment group, there were four cases of surgery, four cases lost to folow-up, and two cases of mild adverse reactions; in the control group, there were six cases of surgery, three cases lost to folow-up, and no adverse reaction. Taken together, smal-needle-knife therapy and physiotherapy both have certain clinical effects on knee osteoarthritis. Smal-needle-knife therapy combined with exercise therapy is superior to physiotherapy combined with exercise therapy in the total efficiency. Folow-up results of 3 months have been confirmed, but long-term effects need further exploration.%背景：小针刀松解法治疗膝骨关节炎定点随意、操作各异，作用机制也众说纷纭。研究证实运动疗法能增强肌力，增加膝关节的稳定性，改善关节的活动范围，能有效缓解疼痛等优点。 目的：通过随机对照临床试验，观察小针刀联合运动疗法治疗膝骨关节炎的临床疗效。 方法：采用随机数字表将122例膝骨关节炎患者随机分为治疗组(n=61)和对照组(n=61)，治疗组给予小针刀治疗，对照组予以低周波理疗，两组同时配合运动训练。统计分析治疗前、治疗后的疼痛目测类比评分、麦克马斯特大学骨关节炎指数问卷调查(W OMAC)、以及膝关节肿胀程度、股四头肌周径、膝关节屈伸活动度来评价两组的临床疗效；同时观察并记录患者的不良反应，评价综合治疗的安全性。 结果与结论：①治疗2周结束后，两组患者目测类比评分法、麦克马斯特大学骨关节炎指数评分，与治疗前相比差异有显著性意义(P <0.05)；目测类比评分法、麦克马斯特大学骨关节炎指数评分治疗组显著低于对照组(P <0.05)。②第12周随访时，治疗组麦克马斯特大学骨关节炎指数评分优于对照组(P <0.05)，治疗组膝关节活动度改善优于对照组(P <0.05)。③全分析集总体有效率比较及符合方案集总体有效率比较，治疗组均优于对照组(P <0.001)。④治疗组有4例手术、4例失访，2例轻度不良反应；对照组有6例手术、3例失访，未出现不良反应。结果说明，小针刀与理疗治疗膝骨关节炎均有一定的临床疗效。小针刀结合运动疗法治疗膝骨关节炎具有短期内改善疼痛的优势，并且在膝关节活动度、身体功能障碍的改善，总体临床疗效的提高方面均优于理疗结合运动疗法，随访3个月疗效确定，长期疗效有待进一步探索。
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