High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia

Capital Medical University

Status

Completed

Conditions

Idiopathic Trigeminal Neuralgia

Treatments

Drug: Nerve block

Device: High-voltage pulsed radiofrequency

Study type

Interventional

Funder types

Other

Identifiers

NCT03131466

KY2017-004-01

Details and patient eligibility

About

The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.

Full description

Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.

Enrollment

134 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
18-75 years old.
Response to drug treatment poorly or unable to tolerate the side effects of drugs.
A BNI pain intensity scale score of IV-V.
Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.
Agree to participate in this trial and have signed the informed consent.

Exclusion criteria

Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.
Abnormal electrocardiogram or chest X-ray results.
Severe cardiopulmonary dysfunction.
Infection at the puncture site.
History of mental illness, or history of narcotic drug abuse.
Allergy to local anesthetic drugs or steroids.
Cannot cooperate with the treatment.
History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.