Pain medicine (Malden, Mass.) · 2021
Masticatory Dysfunction After Computed Tomography-Guided Plasma Ablation vs. Radiofrequency Ablation on Gasserian Ganglion for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Zheng Shuyue, Li Xiuhua, Yang Liqiang, He Liangliang, Cao Guoqing, Yang Zhanmin, Ni Jiaxiang
Аннотация
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.
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.