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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05516888

Enrollment

Registered

2022-08-26

Start date

2022-08-25

Completion date

2023-08-25

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

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.

Interventions

PROCEDUREradiofrequency of gasserian ganglion

radiofrequency ablation of the gasserian ganglion

PROCEDUREradiofrequency of the peripheral trigeminal branches

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026