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

Capital Medical University

Status

Completed

Conditions

Trigeminal Neuralgia

Treatments

Procedure: Low-temperature continuous radiofrequency

Procedure: High-voltage pulsed radiofrequency

Study type

Interventional

Funder types

Other

Identifiers

NCT04174443

KY-2019-266-01

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria.
Aged 18-75 years (inclusive), no sex limitation.
Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine.
Numeric rating scale score≥7 before the procedure.
Agreed to sign the informed consent form.

Exclusion criteria

Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis.
Infection at the puncture site.
A history of psychiatric disease.
Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray.
Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification).
A history of abuse of narcotics.
A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments.
A history of receiving microvascular decompression.