Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Department of Anesthesiology, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7.
Trigeminal neuralgia (TN) is a debilitating pain disorder that still lacks an ideal treatment option. Pulsed radiofrequency (PRF), especially with high output voltage, is a novel and minimally invasive technique. PRF is regarded a promising treatment option for TN patients who respond poorly to medical treatment; however, the available evidence still lacks high quality randomized controlled trials (RCTs). Our study aimed to evaluate the long-term (1 year and 2 years) effects and safety of high-voltage PRF in primary TN patients and provide stronger evidence for TN treatment options.
We performed a multicenter, double-blind, RCT in adults (aged 18-75 years) with primary TN who responded poorly to drug therapy or were unable to tolerate the side effects of drug. Eligible participants were randomly assigned (1:1) to receive either high voltage PRF or nerve block with steroid and local anesthetic drugs. The primary endpoint was the 1-year response rate. This trial has been registered in the clinicaltrials.gov website (registration number: NCT03131466).
One hundred and sixty-two patients were screened for enrollment between April 28th,2017 and September1st, 2019, among whom, 28 were excluded. One hundred and thirty-four participants were randomly assigned to either receive high voltage PRF (n = 67) or nerve block (n = 67). The proportion of patients with a positive response at 1-year after the procedure in the PRF group was significantly higher than that in the nerve block group in the intention-to-treat population (73.1% vs. 32.8%, p < 0.001). There was no difference between groups in the incidence of adverse events.
Our findings support that high voltage PRF could be a preferred interventional choice prior to receiving more invasive surgical treatment or neuro-destructive treatment for TN patients who have poor responses to medical treatment.
Our study has been registered at ClinicalTrials.gov (trial registration number: NCT03131466).
三叉神经痛（TN）是一种使人虚弱的疼痛障碍，目前仍缺乏理想的治疗方法。脉冲射频（PRF），特别是高输出电压，是一种新的微创技术。PRF 被认为是对药物治疗反应不佳或无法耐受药物副作用的 TN 患者的一种有前途的治疗选择；然而，现有的证据仍然缺乏高质量的随机对照试验（RCT）。我们的研究旨在评估高电压 PRF 在原发性 TN 患者中的长期（1 年和 2 年）疗效和安全性，并为 TN 治疗方法提供更有力的证据。
我们在对药物治疗反应不佳或无法耐受药物副作用的原发性 TN 成年患者（18-75 岁）中进行了一项多中心、双盲、RCT。符合条件的参与者被随机分配（1:1）接受高电压 PRF 或类固醇和局部麻醉药物的神经阻滞。主要终点是 1 年的反应率。该试验已在 clinicaltrials.gov 网站（注册号：NCT03131466）注册。
2017 年 4 月 28 日至 2019 年 9 月 1 日期间，共筛选了 162 名患者入组，其中 28 名被排除。134 名参与者被随机分配接受高电压 PRF（n=67）或神经阻滞（n=67）。意向治疗人群中，PRF 组在治疗后 1 年时阳性反应的患者比例明显高于神经阻滞组（73.1%比 32.8%，p<0.001）。两组不良反应发生率无差异。
我们的研究结果支持，对于对药物治疗反应不佳的 TN 患者，高电压 PRF 可能是一种首选的介入治疗选择，可在接受更具侵袭性的手术治疗或神经破坏性治疗之前使用。
我们的研究已在 ClinicalTrials.gov 注册（试验注册号：NCT03131466）。
