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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516888
• Other study ID #: 138/14
• Status: Completed
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 25, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• radiofrequency of gasserian ganglion
radiofrequency ablation of the gasserian ganglion
• radiofrequency of the peripheral trigeminal branches
radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Patient satisfaction	Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)	six months