Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

March 3, 2025 updated by: Burak Erken, Başakşehir Çam & Sakura City Hospital

Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment

Trigeminal neuralgia is common painful disorder in pain medicine clinics. Gasserian ganglion radiofrequency thermocoagulation is one of the treatment option in patients with trigeminal neuralgia in refractory cases. The most commonly involved branch in trigeminal neuralgia is the mandibular branch. Masseter muscle is innervated by mandibulary nerve branch of the trigeminal nerve.

The radiofrequency thermocoagulation therapy is used to ablate the affected trigeminal nerve branch and some of patients complain of subjective masseter weakness after this procedure.

In theoretical basis, muscles innervated by target nerve are affected from ablation procedure. In this study the primary aim is to evaluate the change of the masseter muscle thickness in patients treated by gasserian ganglion radiofrequency thermocoagulation. The results may also show possible functional effect of the procedure related with masseter muscle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Locations

  • Turkey
    • Başakşehir
      • İstanbul, Başakşehir, Turkey
        • Recruiting
        • Başakşehir Çam and Sakura City Hospital
        • Contact:
        • Contact:
        • Contact:
          • Tuba Tanyel Saraçoğlu, Medical Doctor

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pain refractory to medical therapy for at least 3 months
  • Planning radiofrequency thermocoagulation of gasserian ganglion
  • Accept ultrasound measurements to be performed

Exclusion Criteria:

  • Refused to participate in the study
  • Not attending follow-ups regularly
  • Coagulation disorder
  • Pregnancy
  • Localized or systemic infection

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients treated with gasserian ganglion RFT for trigeminal neuralgia
In patients who have undergone radiofrequency thermocoagulation (RFT) of the gasserian ganglion for the treatment of trigeminal neuralgia, the thickness of the masseter muscle will be measured bilaterally, free and contracted, by ultrasound on the day of the procedure (just before the procedure) and at 1 and 3 months after the procedure.
Procedure: Gasserian Ganglion Radiofrequency Thermocoagulation
Gasserian ganglion radiofrequency thermocoagulation is performed in the operating room under fluoroscopy. In sterile condition, the foramen ovale is shown by the pain management specialist under fluoroscopy guidance. After this condition, the entry of the needle is marked and anaesthetised with local anaesthetic. After the entry of the gasserian ganglion with the radiofrequency needle, 10 cm long, the location is checked with sensory and motor stimulation. If the placement is correct, 70 degrees 70 seconds of radiofrequency thermocoagulation is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Masseter muscle thickness
Time Frame: Pre-procedural time
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Pre-procedural time
Masseter muscle thickness
Time Frame: Post-procedural first month
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Post-procedural first month
Masseter muscle thickness
Time Frame: Post-procedural third month
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Post-procedural third month

Collaborators and Investigators

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

Sponsor

Başakşehir Çam & Sakura City Hospital

Investigators

  • Principal Investigator: Tuba Tanyel Saraçoğlu, MD, Başakşehir Çam & Sakura City 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)

March 15, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22.11.2023.589

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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