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

Not Applicable

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Procedure: radiofrequency of the peripheral trigeminal branches; Procedure: radiofrequency of gasserian ganglion

• Registration Number: NCT05516888
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-24
• Study Start: 2022-08-25
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency of peripheral branches of the trigeminal nerve	radiofrequency of the peripheral trigeminal branches	pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve
Radiofrequency of gasserian ganglion	radiofrequency of gasserian ganglion	radiofrequency ablation of the gasserian ganglion

Primary Outcome Measures

Name	Time	Method
The modified Barrow Neurological Institute Pain Intensity Score	six months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey