Effectiveness and safety of high-voltage pulsed radiofrequency to treat patients with primary trigeminal neuralgia: a multicenter, randomized, double-blind, controlled study

J Headache Pain. 2023 Jul 18;24(1):91. doi: 10.1186/s10194-023-01629-7.

Abstract

Background: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: Our study has been registered at ClinicalTrials.gov (trial registration number: NCT03131466).

Keywords: Effectiveness; High-voltage; Pulsed radiofrequency; Safety; Trigeminal neuralgia.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Double-Blind Method
  • Humans
  • Nerve Block*
  • Pulsed Radiofrequency Treatment* / methods
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Trigeminal Neuralgia* / therapy

Associated data

  • ClinicalTrials.gov/NCT03131466