Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

Trial Title: Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

NCT ID: NCT06278194

Condition: Trigeminal Neuralgia
Gasserian Ganglion; Lesion

Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Trigeminal Neuralgia
Neuralgia

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Gasserian Ganglion Radiofrequency Thermocoagulation
Description: 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.
Arm group label: Patients treated with gasserian ganglion RFT for trigeminal neuralgia

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 40 Years

Maximum age: 85 Years

Healthy volunteers: No

Start date: March 15, 2024

Completion date: November 15, 2024

Lead sponsor:
Agency: Başakşehir Çam & Sakura City Hospital
Agency class: Other

Source: Başakşehir Çam & Sakura City Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06278194