Brigham and Women's Hospital, Boston, Massachusetts.
University Orthopedics Center, Altoona, Pennsylvania.
J Bone Joint Surg Am. 2020 Sep 2;102(17):1501-1510. doi: 10.2106/JBJS.19.00935.
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.
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.
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).
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.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
膝骨关节炎是一种疼痛且有时使人虚弱的疾病，常影响患者多年。目前的治疗包括短期且常重复的非手术选择，随后对合适的患者进行手术干预。冷却射频消融（CRFA）是一种治疗膝骨关节炎相关疼痛的微创方法。这项试验比较了 CRFA 与单次透明质酸（HA）注射的疗效和安全性。
260 名膝骨关节炎疼痛对先前非手术方式反应不佳的患者接受了这项多中心、随机试验的筛选。符合纳入标准的 182 名患者接受了诊断性阻滞注射，其中至少有 50%疼痛缓解的患者被随机分配接受 4 个关节突神经的 CRFA 或单次 HA 注射。175 名患者接受了治疗（88 名接受 CRFA，87 名接受 HA）。治疗后 1、3 和 6 个月进行疼痛（数字评分量表[NRS]）、功能（西安大略和麦克马斯特大学骨关节炎指数[WOMAC]）、生活质量（总体感知效果[GPE]评分和欧洲五维健康量表-5 维度[EQ-5D-5L]问卷）评估和安全性。
两组患者的人口统计学特征无显著差异。共有 158 名受试者（CRFA 组 76 名，HA 组 82 名）完成了 6 个月的治疗后随访。在 CRFA 组中，71%的患者 NRS 疼痛评分较基线降低≥50%（主要终点），而 HA 组为 38%（p<0.0001）。6 个月时，CRFA 组 NRS 评分平均降低 4.1±2.2，HA 组为 2.5±2.5（p<0.0001）。从基线开始，CRFA 组 WOMAC 评分改善的平均值为 48.2%，HA 组为 22.6%（p<0.0001）。6 个月时，CRFA 组 72%的患者报告 GPE 评分改善，而 HA 组为 40%（p<0.0001）。
与接受单次 HA 注射治疗的患者相比，接受 CRFA 治疗的患者在疼痛缓解和整体功能方面均有显著改善。两种治疗方法均未出现与治疗相关的严重不良事件，总体不良事件谱相似。
治疗性 1 级。请参见作者指南以获取完整的证据水平描述。
