Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia

Diskapi Teaching and Research Hospital

Status

Completed

Conditions

Headache Disorders

Trigeminal Neuralgia

Treatments

Procedure: Maxillary/Mandibular nerve pulsed radiofrequency

Procedure: Radiofrequency thermocoagulation of the trigeminal ganglion

Study type

Interventional

Funder types

Other

Identifiers

NCT06366139

Trigeminal RFT vs max/mand PRF

Details and patient eligibility

About

Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.

Full description

Trigeminal neuralgia (TN) is a very severe, unilateral, short, lightning-like pain that starts and ends suddenly and is limited to the areas related to the branches of the trigeminal nerve. The pain can be triggered by stimuli such as washing face, shaving, smoking, talking and/or brushing teeth (trigger factors) and usually occurs spontaneously.

Treatment of TN is complex despite the use of multiple medications and may be resistant. Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects. Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular (max/mand) nerve PRF. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation necrosis on nerves.

Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN, there is limited literature data on ultrasonography (US)-guided max/mand nerve PRF.

The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and max/mand nerve PRF for TN. Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events. A total of at least 44 patients, 22 patients in each group, will be enrolled for comparison. NRS, and MQS III scores before treatments, 1 month, and 6 months after treatments will be compared both within and between groups.

Enrollment

44 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with idiopathic TN according to the international headache society
Pain for at least 6 months and numeric rating scale (NRS) score greater than 6 despite medical treatment (despite the maximum tolerated dose of carbamazepine, gabapentinoid or tramadol)

Exclusion criteria

Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
Dental or temporomandibular joint pathologies
Previous interventional procedures or surgery for TN
Coagulopathy or use of antiaggregants and anticoagulants
Cardiac pacemaker
Renal-hepatic insufficiency
Diagnosis of psychiatric illness
Malignancy and
Injection site or systemic infection