Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-25

Study Completion Date

2023-08-25

Brief Summary

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The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.

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Detailed Description

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Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Radiofrequency of peripheral branches of the trigeminal nerve

pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve

Group Type EXPERIMENTAL

radiofrequency of the peripheral trigeminal branches

Intervention Type PROCEDURE

radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)

Radiofrequency of gasserian ganglion

radiofrequency ablation of the gasserian ganglion

Group Type ACTIVE_COMPARATOR

radiofrequency of gasserian ganglion

Intervention Type PROCEDURE

radiofrequency ablation of the gasserian ganglion

Interventions

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radiofrequency of gasserian ganglion

radiofrequency ablation of the gasserian ganglion

Intervention Type PROCEDURE

radiofrequency of the peripheral trigeminal branches

radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
* Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
* Agree to participate in the study

Exclusion Criteria

* Infection at the puncture site.
* Coagulation disorder.
* Abnormal blood test (hepatic or renal function)
* History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No