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

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).

High-voltage pulsed radiofrequency improves ultrastructure of DRG and enhances spinal microglial autophagy to ameliorate neuropathic pain induced by SNI

“…Although the application of HVPRF on DRG have received increasing attention, studies have shown that HVPRF is more effective than SVPRF. Luo et al 7 demonstrated that a higher output voltage and current field intensity increased the analgesic effect for trigeminal neuralgia. Several clinical studies have also shown that increasing the output voltage of PRF can significantly improve refractory neuralgia of the infraorbital nerve 24 , and postherpetic neuralgia 25 without increasing the risk of side effects.…”

“…Pulsed radiofrequency (PRF) is a minimally invasive technology proposed by Sluijter 2 , 4 and has been widely used to manage several types of refractory chronic pain, such as postherpetic neuralgia 5 , cervicogenic headache 6 and trigeminal neuralgia 7 . This technique works by delivering electrical fields and thermal pulses through the catheter tip to the target nerve or tissue without damaging these structures, and the clinical standard PRF parameters are as follows: the output voltage is 45 V, the current action time is 20 ms, the intermittent period is 480 ms, the oscillating frequency of the alternating current is 500 kHz and the maximum temperature of the electrode does not exceed 42 °C 8 .…”

Bipolar, high-voltage, long-duration pulsed radiofrequency ablation of the Gasserian ganglion for the treatment of trigeminal neuralgia in a patient with a cardiac implantable electronic device: illustrative case

“…To avoid the above complications, we used PRFT in our clinical case. 22 PRFT was introduced by Sluijter in 1998. Since that time, PRFT has been widely used for various types of pain.…”

A Comparison Between the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-Guided Maxillary-Mandibular Nerve Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia: A Randomized Clinical Trial

“…PRF has emerged as a promising alternative to RFT. PRF is a minimally invasive procedure that offers significant advantages, primarily its non-destructive nature, which helps avoid complications commonly associated with conventional RFT [ 16 , 17 ]. PRF has a distinct and beneficial mechanism of action.…”