NCT04174443: PRFCRF

The Efficacy and Safety of Pulsed Radiofrequency Combined With Continuous Radiofrequency for the Trigeminal Neuralgia

Completed NA Last updated 6 August 2024

What this trial tests

NA trial testing High-voltage pulsed radiofrequency in Trigeminal Neuralgia in 146 participants. Completed in 26 October 2022.

Timeline

2 December 2020

Primary endpoint
26 October 2022

26 October 2022

Quick facts

Lead sponsor	Beijing Tiantan Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	146
Start date	2 December 2020
Primary completion	26 October 2022
Estimated completion	26 October 2022
Sites	1 location across China

Drugs / interventions tested

• High-voltage pulsed radiofrequency
• Low-temperature continuous radiofrequency

Conditions studied

• Trigeminal Neuralgia — all drugs for Trigeminal Neuralgia →

Sponsor

Beijing Tiantan Hospital

Who can join

Adults 18 to 75, any sex, with Trigeminal Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Recently, studies have found that pulsed radiofrequency combined with low-temperature (\<65 °C) continuous radiofrequency increases the efficacy of the treatment, without leading to a significant increase in complications caused by nerve lesions. However, these reports have some limitations. The investigators plan to conduct a randomized, controlled study to compare the efficacy of applying high-voltage pulsed radiofrequency, with and without low-temperature continuous radiofrequency, to the gasserian ganglion for the treatment of trigeminal neuralgia. The primary outcome will be the effectiveness of the treatment after 12 months which is the percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score between I-III.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-Temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia: Study Protocol for a Prospective, Open-Label, Parall.
   Ren H, Zhao C, Wang X, Shen Y, et al · · 2021 · cited 9× · PMID 33400432
2. The efficacy of combining pulsed radiofrequency with low-temperature continuous radiofrequency for the treatment of primary trigeminal neuralgia: a randomized controlled trial.
   Zhao C, Ren H, Shrestha N, Meng L, et al · · 2025 · PMID 40053922 · DOI 10.3171/2024.10.jns241274