Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
All Genders
ID06278194

Change of Masseter Muscle Thickness Measured by Ultrasound After Gasserian Ganglion Radiofrequency Thermocoagulation Treatment

Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-03-05

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

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AI-Summary

What this Trial Is About

Trigeminal neuralgia is a common painful disorder often seen in pain clinics. This research aims to evaluate how the thickness of the masseter muscle changes after patients receive gasserian ganglion radiofrequency thermocoagulation, a treatment used especially for cases where other therapies have not worked. The study focuses on the mandibular branch of the trigeminal nerve, which controls the masseter muscle, to understand any possible functional effects of this procedure. The treatment involves performing radiofrequency thermocoagulation under fluoroscopy guidance in a sterile operating room. A needle is positioned at the gasserian ganglion after local anesthesia and confirmed with sensory and motor tests. Then, radiofrequency heat is applied for 70 seconds at 70 degrees to affect the nerve. This study measures the thickness of the masseter muscle on both sides, both at rest and when contracted, by ultrasound before the procedure and at 1 and 3 months afterward. Participants will undergo ultrasound measurements on the day of treatment and at follow-up visits one month and three months later. The study monitors changes in masseter muscle thickness over these time points as the main outcome. The research tracks the muscle's response to the nerve ablation procedure to assess potential effects on muscle function. Participation includes regular follow-up visits to ensure consistent data collection and safety.

CONDITIONS

Brief Title

Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pain refractory to medical therapy for at least 3 months
  • Planning radiofrequency thermocoagulation of gasserian ganglion
  • Accept ultrasound measurements to be performed
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 day

Participants undergo Gasserian ganglion radiofrequency thermocoagulation for trigeminal neuralgia in the operating room under fluoroscopy guidance.

1 procedure visit (in-person)

Follow-up

Duration - 3 months

Participants have ultrasound measurements of masseter muscle thickness performed on the day of the procedure (before treatment) and at 1 and 3 months after the procedure to assess changes.

3 visits (in-person): baseline on procedure day, 1 month, and 3 months post-procedure

Trial Site Locations

Total: 1 location

1

Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Burak Erken, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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