Comparison of Two Types of Radiofrequency Treatment for Trigeminal Neuralgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorMesut Bakır
About this trial
Trigeminal neuralgia (TN) is a chronic pain condition that affects the face, often causing sharp, electric shock-like pain in areas served by the trigeminal nerve. When medications are no longer effective, interventional procedures such as radiofrequency ablation (RFA) may be used. This retrospective study compares two different RFA techniques in patients with classical TN: (1) conventional thermal RFA applied to the Gasserian ganglion, and (2) pulsed RFA applied peripherally to the nerve branches.
The purpose of the study is to evaluate pain relief, patient satisfaction, and complication rates between these two commonly used techniques. A total of 60 patients aged 55-80 years, who were treated at the Mersin University Pain Clinic between January 2015 and June 2025, were included. The study uses clinical records and follow-up data to assess outcomes at 6 months post-procedure.
This study aims to provide clinicians with more evidence to guide the selection of safer and more effective treatments for trigeminal neuralgia, with the goal of improving patients' quality of life and reducing treatment-related side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 55 and 80 years with a diagnosis of classical trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Patients must have experienced pain refractory to medical management for at least 6 months and have complete clinical and procedural records available, including follow-up data for a minimum of 6 months.
Disqualifiers
Patients with secondary trigeminal neuralgia due to structural causes such as multiple sclerosis or tumors, those with a history of prior craniofacial surgery or neuroablative procedures, patients lacking sufficient follow-up data, and those with contraindications to sedation or with uncontrolled systemic comorbidities are excluded from the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Gasserian Ganglion Radiofrequency
Procedure/SurgeryConventional RFA was performed at the Gasserian ganglion under fluoroscopic guidance with thermal lesioning at 70-75°C for up to 90 seconds. Sensory and motor stimulation were used to verify needle placement.
Peripheral Pulsed Radiofrequency
Procedure/SurgeryPRF was applied to the peripheral branch of the trigeminal nerve at 42°C for two cycles of 120 seconds using fluoroscopic guidance. This technique was preferred in our clinic to avoid thermal complications such as hypoesthesia or motor dysfunction.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Conventional RadiofrequencyActive comparator 1 intervention
Group B: Peripheral Pulsed RadiofrequencyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity Reduction
Change in pain intensity score measured on the Numerical Rating Scale (NRS) from baseline to 6 months post-procedure.
Time frame
Baseline and 6 months after interventionSecondary outcomes
1
Patient Satisfaction Score
Patient-reported satisfaction with the intervention, measured using a 5-point Likert scale at the 6-month follow-up visit.
Time frame
6 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mesut Bakır
Lead sponsor
Mersin University
Sponsor institution
Source ClinicalTrials.gov
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