Ireland
--:--IST
Recruiting Not applicable

Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment

NCT06278194 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-03-15
Last updated
2025-03-05

Condition(s) studied

Trigeminal NeuralgiaGasserian Ganglion; Lesion

Investigational drug(s) / intervention(s)

Gasserian Ganglion Radiofrequency Thermocoagulation

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.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Masseter muscle thickness — Pre-procedural time
    The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
  • Masseter muscle thickness — Post-procedural first month
    The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
  • 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 sites (1)

FacilityCityRegionStatus
Başakşehir Çam and Sakura City Hospital Istanbul Başakşehir Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06278194 on ClinicalTrials.gov ↗ ← All trials in Turkey