Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

Not Applicable

Recruiting

• Conditions: Trigeminal Neuralgia; Gasserian Ganglion; Lesion
• Interventions: Procedure: Gasserian Ganglion Radiofrequency Thermocoagulation

• Registration Number: NCT06278194
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-26
• Study Start: 2024-03-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-07-15
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with gasserian ganglion RFT for trigeminal neuralgia	Gasserian Ganglion Radiofrequency Thermocoagulation	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.

Primary Outcome Measures

Name	Time	Method
Masseter muscle thickness	Post-procedural third month	The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 İstanbul, Başakşehir, Turkey