Clinical trial NCT06366139: Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia
Official title: Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Headache Disorders
Keywords: Pulsed Radiofrequency Treatment
Radiofrequency Ablation
Maxillary Nerve
Mandibular Nerve
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Change from baseline to 1st and 6th month after treatment
Secondary outcomes:
measure: The Medication Quantification Scale III (MQS III)
timeFrame: Change from baseline 6th month after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
Study officials:
affiliation: Diskapi TRH
name: Gevher Rabia Genc Perdecioğlu
role: STUDY_CHAIR
References: