Trigeminal NeuralgiaTN-RFA-MEU25NCT07013500
Comparison of Two Types of Radiofrequency Treatment for Trigeminal Neuralgia
A study testing Conventional Gasserian Ganglion Radiofrequency and Peripheral Pulsed Radiofrequency in people with Trigeminal Neuralgia and Tic Douloureux, run by Mesut Bakır at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia, Tic Douloureux, Neuropathic Facial Pain
- What is being tested?
- Conventional Gasserian Ganglion Radiofrequency and Peripheral Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 30 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Department of Algology
Mersin, Mersin, 33110
Mesut Bakır, Assoc. Prof., +90 545 745 06 55, mesutbakir@mersin.edu.tr
About this study
Official title: Comparison of Gasserian Ganglion Conventional Radiofrequency and Peripheral Pulsed Radiofrequency in Trigeminal Neuralgia
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.
Read the detailed description
Trigeminal neuralgia (TN) is a debilitating neuropathic condition characterized by recurrent episodes of severe, lancinating facial pain in the distribution of one or more branches of the trigeminal nerve. Although most patients initially respond to medical therapy such as carbamazepine or oxcarbazepine, a subset remains refractory and requires interventional treatment.
Radiofrequency ablation (RFA) has been widely used in the management of refractory TN, especially conventional thermal RFA targeting the Gasserian ganglion. While this approach offers substantial pain relief, it may lead to complications such as facial numbness, dysesthesia, or weakness due to irreversible nerve damage. As an alternative, pulsed RFA (PRF) offers neuromodulation without causing structural nerve injury and is often preferred for peripheral branch interventions.
This retrospective cohort study aims to compare the effectiveness and safety of two RFA techniques in patients with classical TN:
Group A: Conventional RFA applied to the Gasserian ganglion
Group B: Pulsed RFA applied peripherally to the affected branch (V1, V2, or V3)
Patients were selected from the records of the Pain Clinic of Mersin University Faculty of Medicine between January 1, 2015, and June 1, 2025. A total of 60 patients aged 55-80 years, who had been diagnosed with classical TN (per ICHD-3 criteria), were included. All patients had failed medical management for at least 6 months and underwent either of the RFA techniques described above. Patients with secondary TN, prior craniofacial surgery, or missing follow-up data were excluded.
PRF was specifically chosen for peripheral interventions in our clinic to avoid thermal-related complications. PRF was applied at 42°C for two cycles of 120 seconds. Thermal RFA was applied with standard lesioning parameters following contrast-confirmed Gasserian ganglion targeting.
Outcome measures included:
Primary: Pain relief measured using a numerical rating scale (NRS) at baseline and 6 months post-procedure
Secondary: Patient satisfaction (5-point Likert scale), rate of complications, and recurrence of pain requiring reintervention
All procedures were performed under fluoroscopic guidance by experienced pain specialists. Data was extracted from electronic records and procedure reports. Statistical comparisons will be made using appropriate parametric or non-parametric tests based on data distribution.
This study seeks to contribute real-world evidence to guide clinicians in selecting safer, more effective RFA strategies for managing TN, particularly in patients at risk for complications or those preferring less invasive approaches.
- Being tested
- Conventional Gasserian Ganglion Radiofrequency, Peripheral Pulsed Radiofrequency
- Keywords
- Trigeminal Neuralgia, Radiofrequency Ablation, Pulsed Radiofrequency, Gasserian Ganglion, Neuropathic Pain
- Medical subject headings
- Trigeminal Neuralgia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Gasserian Ganglion RadiofrequencyProcedure or surgery
Conventional 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 RadiofrequencyProcedure or surgery
PRF 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Radiofrequency | Active comparator | Patients in this group received conventional thermal radiofrequency (RFA) treatment targeting the Gasserian ganglion. The procedure was performed under fluoroscopic guidance using standard techniques. Lesioning was applied at 70-75°C for 60-90 seconds after correct positioning was confirmed with sensory and motor stimulation. Receives: Procedure: Conventional Gasserian Ganglion Radiofrequency |
| Peripheral Pulsed Radiofrequency | Experimental | Patients in this group received pulsed radiofrequency (PRF) applied peripherally to the affected branch of the trigeminal nerve (V1, V2, or V3), depending on the pain distribution. The procedure was performed under fluoroscopic guidance. PRF was applied at 42°C for two cycles of 120 seconds. Receives: Procedure: Peripheral Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Reduction
Change in pain intensity score measured on the Numerical Rating Scale (NRS) from baseline to 6 months post-procedure.
Measured: Baseline and 6 months after intervention
Secondary 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.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mesut Bakır
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Bakır, Mersin University
- Investigators
- Mesut Bakır, Assoc. Prof, Principal investigator, Mersin University Faculty of Medicine, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013500
- Sponsor's protocol ID
- MERSINALG-TN-RFA-2025
- Acronym
- TN-RFA-MEU25
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes will be shared upon reasonable request. Data will be available after publication and can be requested by contacting the principal investigator.
Publications
Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30.
PubMed 21116663Bakir M, Turkyilmaz GG, Teker N, Yavuz K, Ilcan B, Rumeli S. Comparison of Gasserian ganglion conventional radiofrequency ablation and peripheral nerve pulsed radiofrequency in trigeminal neuralgia: a retrospective cohort study. J Oral Facial Pain Headache. 2026 Jan;40(1):119-126. doi: 10.22514/jofph.2025.063. Epub 2026 Jan 12.
PubMed 41607329