NCT04174443

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
PROCEDURE	High-voltage pulsed radiofrequency	2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.
PROCEDURE	Low-temperature continuous radiofrequency	Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2019-11-22
• Last updated: 2024-08-06

Locations

1 site across 1 country: China