NCT06278194|Recruiting
Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment
Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
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Change of the Masseter Muscle Thickness Measured by Ultrasonography After Gasser Ganglion Radiofrequency Thermocoagulation Treatment
Sponsor study identifier
interventional
30
1 country
1
Study Start
March 15, 2024
Actual (reported)Primary Completion
July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2024
Actual (reported)February 26, 2024
Actual (reported)March 15, 2024
Actual (reported)July 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Pre-procedural time
Masseter muscle thickness
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
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Post-procedural third month
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.
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.
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Başakşehir Çam and Sakura City Hospital
Istanbul, Başakşehir, Turkey (Türkiye)
Tuba Tanyel Saraçoğlu, MD
Başakşehir Çam & Sakura City Hospital
First Submitted
February 15, 2024
First Posted
February 26, 2024
Study Start
March 15, 2024
Actual (reported)Primary Completion
July 15, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 5, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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