Background: 

Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection.

Methods: 

Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment.

Results: 

Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001).

Conclusions: 

CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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与单次注射透明质酸治疗慢性膝关节疼痛相比，冷射频消融：一项多中心，随机临床试验，显示了冷射频消融的疗效和等效安全性。

背景： 

膝关节骨关节炎是一种痛苦的，有时使人衰弱的疾病，常影响患者数年。目前的治疗方法包括持续时间短且经常重复的非手术选择，然后对适当的候选人进行手术干预。冷却射频消融（CRFA）是一种微创手术，用于治疗与膝骨关节炎有关的疼痛。该试验将CRFA的功效和安全性与单次透明质酸（HA）注射的功效和安全性进行了比较。

方法： 

该多中心随机试验筛选了260名对先前的非手术方式反应不足的膝骨关节炎疼痛患者。符合入组标准的一百八十二名受试者接受了诊断性块状注射，疼痛缓解率至少达到50％的受试者被随机分配接受四根神经的CRFA或单次HA注射。对175名受试者进行了治疗（CRFA为88名，HA为87名）。疼痛（数字评分量表[NRS]），功能（西安大略省和麦克马斯特大学骨关节炎指数[WOMAC]），生活质量（全球感知效果[GPE]评分和EuroQol-5维度5级[EQ-5D- 5L]问卷），并在治疗后1、3和6个月进行安全性检查。

结果： 

两个研究组之间的人口统计学特征无显着差异。共有158位受试者（CRFA组为76位，HA组为82位）完成了治疗后6个月的随访。在CRFA组中，有71％的受试者的NRS疼痛评分（主要终点）降低了50％以上，而HA组则为38％（p <0.0001）。在6个月时，CRFA组的平均NRS得分降低为4.1±2.2，而HA组为2.5±2.5（p <0.0001）。CRFA组从基线开始6个月的平均WOMAC评分改善为48.2％，HA组为22.6％（p <0.0001）。在6个月时，CRFA组中72％的受试者报告GPE评分有所改善，而HA组中则为40％（p <0.0001）。

结论： 

与单次注射HA治疗的受试者相比，CRFA治疗的受试者在疼痛缓解和总体功能方面显示出显着改善。没有发现与任何一种手术相关的严重不良事件，并且总体不良事件情况相似。

证据级别： 

治疗I级。有关证据水平的完整说明，请参见《作者说明》。