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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
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Start Date
December 2, 2020
Primary Completion Date
October 26, 2022
Completion Date
October 26, 2022
Last Updated
August 6, 2024
146
ACTUAL participants
High-voltage pulsed radiofrequency
PROCEDURE
Low-temperature continuous radiofrequency
PROCEDURE
Lead Sponsor
Beijing Tiantan Hospital
NCT05152368
NCT06863324
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06724029