Vallejo Ricardo, Benyamin Ramsin, Orduña-Valls Jorge, Vallejo Alejandro, Thomas Samuel M, Cedeño David L
Millennium Pain Center, 2406 E. Empire St., Bloomington, IL, 61704, USA.
Lumbrera Research, 33 Derby Way, Bloomington, IL, 61704, USA.
Interv Pain Med. 2023 Apr 10;2(2):100249. doi: 10.1016/j.inpm.2023.100249. eCollection 2023 Jun.
Chronic knee pain due to osteoarthritis (OA) is expected to become more prevalent. Although conventional therapies may provide relief they are not long-lasting. Persistent pain may lead to total knee replacement, which is not free of adverse outcomes. Monopolar and cooled radiofrequency ablation (RFA) of genicular nerves is an effective option. However, either method may provide distinctive results depending on expected lesion size, a key aspect considering the anatomical variability of knee innervations. This prospective, double-blind, randomized controlled trial evaluated the efficacy and durability of knee RFA using a cooled probe or a monopolar probe of comparable diameter.
This investigator-initiated, post-market, double-blinded, prospective, randomized controlled trial was approved by the Western IRB. 79 subjects with chronic knee pain due to knee OA were enrolled in multiple locations of a single center. 75 subjects were randomized (1:1) into RFA treatment with either a 4 mm/17G cooled active tip (CRFA) or a 10 mm/16G monopolar active tip (MRFA) using conventional procedures. Primary endpoint was change in knee pain level (100 mm VAS score) from baseline at 24-week post-treatment. Other endpoints include change in functionality, global perceived effect, and frequency of adverse events. Evaluation spanned to 52-week post-treatment. Significance of results (p < 0.05) was calculated using standard statistical analyses.
Both CRFA and MRFA provided significant reduction (41 mm and 39 mm, respectively) of chronic knee pain at 24-week. At the 52-week visit, reduction in pain level was sustained for CRFA (42 mm) but seems to decrease for MRFA (31 mm). Improvements in functionality were also significant and sustained with both treatments, although tend to decrease with MRFA at 52-week. Most patients also perceived a very good/good effect of treatments along the duration of the study.
RFA of knee genicular nerves for the treatment of OA chronic pain is effective for 52 weeks post-ablation when using a CRFA (4 mm/17G active tip) or MRFA (10 mm/16G active tip). The benefits of CRFA seems to be better sustained beyond 24 weeks than the ones of MRFA, although no significant differences were observed at 52 weeks.
由于骨关节炎（OA）导致的慢性膝关节疼痛预计会变得更加普遍。尽管传统疗法可能会缓解疼痛，但效果并不持久。持续疼痛可能会导致全膝关节置换，而这并非没有不良后果。膝关节神经的单极和冷循环射频消融（RFA）是一种有效的选择。然而，根据预期的损伤大小，这两种方法可能会产生不同的结果，这是考虑到膝关节神经支配的解剖变异性的一个关键因素。这项前瞻性、双盲、随机对照试验评估了使用直径相当的冷循环探头或单极探头进行膝关节RFA的疗效和持久性。
这项由研究者发起的上市后双盲前瞻性随机对照试验已获得西部机构审查委员会的批准。在单一中心的多个地点招募了79名因膝关节OA导致慢性膝关节疼痛的受试者。75名受试者使用传统程序随机（1:1）分为使用4毫米/17G冷循环活性尖端（CRFA）或10毫米/16G单极活性尖端（MRFA）进行RFA治疗。主要终点是治疗后24周时膝关节疼痛水平（100毫米视觉模拟评分）相对于基线的变化。其他终点包括功能变化、总体感知效果和不良事件发生频率。评估持续到治疗后52周。使用标准统计分析计算结果的显著性（p < 0.05）。
CRFA和MRFA在治疗后24周时均显著减轻了慢性膝关节疼痛（分别为41毫米和39毫米）。在52周随访时，CRFA的疼痛水平降低持续存在（42毫米），而MRFA的疼痛水平似乎有所下降（31毫米）。两种治疗方法在功能方面的改善也很显著且持续存在，尽管在52周时MRFA的改善趋势有所下降。在研究期间，大多数患者也认为治疗效果非常好/良好。
使用CRFA（4毫米/17G活性尖端）或MRFA（10毫米/16G活性尖端）对膝关节神经进行RFA治疗OA慢性疼痛在消融后52周内是有效的。CRFA的益处似乎比MRFA在24周后更能持续，尽管在52周时未观察到显著差异。
