期刊论文详细信息
The Journal of Headache and Pain
Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study
Research
Hao Cheng1  Yitong Jia2  Kunpeng Feng2  Fang Luo3  Chunmei Zhao3  Hao Ren3  Niti Shrestha3 
[1]Department of Anesthesiology, Beijing Ditan Hospital, Capital Medical University, Beijing, China
[2]Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, China
[3]Department of Pain Management, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
关键词: Trigeminal neuralgia;    Effectiveness;    Safety;    High-voltage;    Pulsed radiofrequency;   
DOI  :  10.1186/s10194-023-01629-7
 received in 2023-05-16, accepted in 2023-07-10,  发布年份 2023
来源: Springer
PDF
【 摘 要 】
BackgroundTrigeminal 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.MethodsWe 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).ResultsOne 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.ConclusionsOur 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.Trial registrationOur study has been registered at ClinicalTrials.gov (trial registration number: NCT03131466).
【 授权许可】

CC BY   
© The Author(s) 2023

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