BACKGROUND This study is comparing thermal radiofrequency ablation (TRFA) of the thoracic dorsal root ganglia (TDRG) guided by Xper CT and fluoroscopy with the standard fluoroscopy. METHODS This randomized clinical trial included 78 patients suffering from chronic refractory pain due to chest malignancies randomly allocated into one of two groups according to guidance of TRFA of TDRG. In CT guided group (n = 40) TRFA was done under integrated Xper CT-scan and fluoroscopy guidance, while it was done under fluoroscopy guidance only in standard group (n = 38). The primary outcome was pain intensity measured by visual analog scale (VAS) score, functional improvement and consumption of analgesics. The secondary outcome measures were patient global impression of changes (PGIC) and adverse effects. RESULTS VAS scores decreased in the two groups compared to baseline values (p < 0.001) and were lower in CT guided group up to 12 weeks. Pregabalin and oxycodone consumption was higher in the standard group at 1, 4 and 12 weeks (p < 0.001). Functional improvement showed near significant difference between the two groups (P = 0.06 at week 1, 0.07 at week 4 respectively) while the difference was statistically significant at week 12 (P = 0.04). PGIC showed near significant difference only at week 1 (P = 0.07) while the per-patient adverse events were lower in CT guided group (p = 0.027). CONCLUSIONS Integrated modality guidance with Xper CT-scan and fluoroscopy together with suprapedicular inferior transforaminal approach may improve efficacy and safety of TRFA of TDRG for the treatment of intractable chest pain in cancer patients. TRIAL REGISTRATION The study was retrospectively registered at clinicaltrials.gov on 04/22/2018 (Registration No.: NCT03533413).

中文翻译：

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联合透视和CT引导下改良的胸背根神经节热射频消融技术：一项随机临床试验。

背景技术这项研究将Xper CT引导下的胸部背根神经节（TDRG）的热射频消融（TRFA）和荧光检查与标准荧光检查进行了比较。方法该随机临床试验纳入78例因胸部恶性肿瘤而导致的慢性顽固性疼痛的患者，根据TDRG的TRFA指南将其随机分为两组。在CT引导组（n = 40）中，TRFA是在Xper CT扫描和荧光透视的综合指导下完成的，而仅在荧光透视指导下在标准组中进行（n = 38）。主要结果是通过视觉模拟量表（VAS）评分，功能改善和镇痛药的使用来测量疼痛强度。次要结果指标是患者对变化的整体印象（PGIC）和不良反应。结果与基线值相比，两组的VAS评分均降低（p <0.001），而在CT引导组中，VAS评分降低了12周。在第1、4和12周时，标准组中普瑞巴林和羟考酮的消耗量较高（p <0.001）。两组之间的功能改善表现出近乎显着的差异（在第1周，P = 0.06，在第4周分别为0.07），而在第12周，差异有统计学意义（P = 0.04）。PGIC仅在第1周时才显示出显着差异（P = 0.07），而CT引导组的每位患者不良事件更低（p = 0.027）。结论结合Xper CT扫描和荧光透视的模态引导以及蛛网膜下下腔入路可以提高TDRG TRFA治疗难治性胸痛的疗效和安全性。