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

Study Overview
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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.

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.

Official Title
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A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Procedure: radiofrequency of gasserian ganglion
* Procedure: radiofrequency of the peripheral trigeminal branches


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency of peripheral branches of the trigeminal nerve<br>pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve | Procedure: radiofrequency of the peripheral trigeminal branches<br>* radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)<br>|
| Active Comparator: Radiofrequency of gasserian ganglion<br>radiofrequency ablation of the gasserian ganglion | Procedure: radiofrequency of gasserian ganglion<br>* radiofrequency ablation of the gasserian ganglion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Barrow Neurological Institute Pain Intensity Score | The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief). | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale | Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable). | baseline to six months | 
| Patient satisfaction | Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent) | six months |