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

September 3, 2023 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline to six months
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)
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 25, 2023

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 138/14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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