Masseter Muscle Thickness in Gasser Ganglion Radiofrequency Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorBaşakşehir Çam & Sakura City Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Pain refractory to medical therapy for at least 3 months
Planning radiofrequency thermocoagulation of gasserian ganglion
Accept ultrasound measurements to be performed
Disqualifiers
Refused to participate in the study
Not attending follow-ups regularly
Coagulation disorder
Pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Gasserian Ganglion Radiofrequency Thermocoagulation
Procedure/SurgeryGasserian 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients treated with gasserian ganglion RFT for trigeminal neuralgiaOther 1 intervention
Trial outcomes
Primary outcomes
1
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame
Pre-procedural time2
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame
Post-procedural first month3
Masseter muscle thickness
The thickness of the masseter muscle will be measured and recorded by ultrasound while bilaterally contracted and relaxed.
Time frame
Post-procedural third monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov