Masticatory Dysfunction After Computed Tomography–Guided Plasma Ablation vs. Radiofrequency Ablation on Gasserian Ganglion for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial

Abstract

Abstract Objective We aimed to evaluate masticatory dysfunction after two different types of ablation on the Gasserian ganglion for the treatment of idiopathic trigeminal neuralgia. We hypothesized that low-temperature plasma radiofrequency ablation (LTP-RFA) was noninferior to radiofrequency thermocoagulation (RFT) with respect to initial efficacy. Methods In the randomized, single-blind, parallel-group, noninferiority trial, 204 participants with idiopathic trigeminal neuralgia were randomly allocated to receive plasma ablation in the LTP-RFA group and radiofrequency ablation in the RFT group in a 1:1 ratio, with random block sizes of four or six. Participants were examined at baseline (T0), on the day of discharge (T1), and at the 6-month follow-up (T2). The primary end point was the clinincal effective rate in the LTP-RFA group compared with that in the RFT group after intervention on the day of discharge. Noninferiority was prespecified at -10%. Results The intention-to-treat analysis revealed that the initial efficacy rates were 91.2% in LTP-RFA group and 93.1% in RFT group (rate ratio [RR] = 0.979, 95% confidence interval [CI]: 0.904–1.061, P = 0.795). The difference between the two groups was 1.9% (95% CI: -5.6% to 9.4%), which showed that LTP-RFA demonstrated noninferiority compared with RFT in initial efficacy. Compared with the RFT group, the LTP-RFA group exhibited a significantly greater improvement in the maximum voltage of the masseter muscles with mean differences of 11.40 (95% CI: 10.52 to 12.27, P < 0.001) at T1 and 17.41 (95% CI: 14.68 to 20.13, P < 0.001) at T2, respectively. Similar results were observed for the asymmetry index of occlusion, the maximum voltage of the anterior temporalis, and the activity index of anterior temporalis / masseter muscles. No serious adverse events were observed in either group. Conclusions Compared with the RFT group, noninferior efficacy for pain relief and improvement of masticatory function was revealed in the LTP-RFA group.