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Completed

NCT Number: NCT05516888

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

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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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

radiofrequency of gasserian ganglion

Procedure

radiofrequency ablation of the gasserian ganglion

radiofrequency of the peripheral trigeminal branches

Procedure

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

Primary outcomes

  1. The modified Barrow Neurological Institute Pain Intensity Score

    Time frame: 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 outcomes

  1. Numeric rating scale

    Time frame: baseline to six months

    Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).

  2. Patient satisfaction

    Time frame: six months

    Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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