Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial.
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).
['Reyad|Raafat M|RM|', 'Ghobrial|Hossam Z|HZ|', 'Shaker|Ehab H|EH|0000-0002-6182-632X', 'Reyad|Ehab M|EM|', 'Shaaban|Mohammed H|MH|', 'Hashem|Rania H|RH|', 'Darwish|Wael M|WM|']
D000368:Aged D000700:Analgesics D000072716:Cancer Pain D002637:Chest Pain D059350:Chronic Pain D005260:Female D005471:Fluoroscopy D005727:Ganglia, Spinal D006801:Humans D008297:Male D008875:Middle Aged D010147:Pain Measurement D000078703:Radiofrequency Ablation D016037:Single-Blind Method D013899:Thoracic Neoplasms D014057:Tomography, X-Ray Computed D016896:Treatment Outcome
Thermal radiofrequency ablation Dorsal root ganglia Chest malignancies Transforaminal approach Intractable pain Suprapedicular approach