Research and Development, Avanos Medical Inc, Alpharetta, Georgia, USA
Research and Development, Avanos Medical Inc, Alpharetta, Georgia, USA.
Reg Anesth Pain Med. 2020 Oct;45(10):792-798. doi: 10.1136/rapm-2020-101361. Epub 2020 Aug 11.
Several clinical studies have focused on assessing the effectiveness of different radiofrequency ablation (RFA) modalities in pain management. While a direct head-to-head clinical study is needed, results from independent studies suggest that water-cooled RFA (CRFA) may result in longer lasting pain relief than traditional RFA (TRFA). The primary purpose of this study was, therefore, to investigate in a preclinical model, head-to-head differences between the two RFA technologies.
RFA was performed in a rat sciatic nerve model (n=66) in two groups: (1) TRFA or (2) CRFA. The surgeon was not blinded to the treatment; however, all the physiological endpoints were assessed in a blinded fashion which include histological, MRI, and nerve function assessment via electromyography.
The energy delivered by the generator for CRFA was significantly higher compared with TRFA. Histological staining of nerves harvested immediately following CRFA exhibited extended length and multiple zones of thermal damage compared with TRFA-treated nerves. MRI scans across 4 weeks following treatment showed edematous/inflammatory zones present for longer times following CRFA. Finally, there was greater attenuation and prolonged loss of nerve function measured via electromyography in the CRFA group.
This study shows that CRFA has greater energy output, as well as more pronounced structural and functional changes elicited on the peripheral nerves compared with TRFA. While these preclinical data will need to be confirmed with a large clinical randomized controlled trial, we are encouraged by the direction that they may have set for those trials.
多项临床研究集中于评估不同射频消融(RFA)方式在疼痛管理中的有效性。虽然需要进行直接的头对头临床研究,但独立研究的结果表明,水冷射频消融(CRFA)可能比传统射频消融(TRFA)产生更持久的疼痛缓解。因此,本研究的主要目的是在临床前模型中研究两种 RFA 技术的头对头差异。
在大鼠坐骨神经模型中(n=66)进行 RFA,分为两组:(1)TRFA 或(2)CRFA。外科医生对治疗没有进行盲法处理;然而,所有生理终点均以盲法方式进行评估,包括组织学、MRI 和通过肌电图评估神经功能。
CRFA 中发生器输送的能量明显高于 TRFA。CRFA 处理后立即采集的神经组织学染色显示,与 TRFA 处理的神经相比,热损伤的长度和多个区域都有扩展。治疗后 4 周的 MRI 扫描显示,CRFA 后水肿/炎症区域存在时间更长。最后,通过肌电图测量,CRFA 组的神经功能衰减更大且丧失时间更长。
本研究表明,与 TRFA 相比,CRFA 具有更高的能量输出,以及在外周神经上引起更明显的结构和功能变化。虽然这些临床前数据需要通过大型临床随机对照试验来证实,但它们为这些试验指明了方向,我们对此感到鼓舞。