Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

NCT ID: NCT06278194

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-10-15

Brief Summary

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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

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Conditions

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Trigeminal Neuralgia Gasserian Ganglion; Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Gasserian Ganglion Radiofrequency Thermocoagulation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Burak Erken

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuba Tanyel Saraçoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

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Başakşehir Çam and Sakura City Hospital

Istanbul, Başakşehir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Burak Erken, MD

Role: CONTACT

+0902129096000

Facility Contacts

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Burak Erken, Medical Doctor

Role: primary

+0902129096000

Tuba Tanyel Saraçoğlu, MD

Role: backup

Other Identifiers

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22.11.2023.589

Identifier Type: -

Identifier Source: org_study_id

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