CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia

This randomized controlled trial aims to compare the efficacy and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in patients with idiopathic trigeminal neuralgia (TN). Idiopathic TN is characterized by severe, recurrent facial pain, and radiofrequency thermocoagulation is a common interventional treatment option.

Participants eligible for this study will be adults over 18 years old, diagnosed with idiopathic TN based on the International Headache Society criteria, experiencing pain for at least six months with a numeric rating scale (NRS) score greater than 6 despite medical treatment.

Exclusion criteria

include vascular compression of the trigeminal nerve by MRI, secondary causes such as multiple sclerosis, trigeminal autonomic cephalalgias, dental or temporomandibular joint pathologies, previous interventional procedures or surgery for TN, coagulopathy, use of antiaggregants and anticoagulants, cardiac pacemaker, renal-hepatic insufficiency, psychiatric illness, malignancy, or infection at the injection site or systemic infection.

Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The CT-guided RFT will use real-time CT imaging for needle placement and monitoring, while the fluoroscopy-guided RFT will use fluoroscopic imaging.

The primary outcome measure is pain relief, assessed at 1-, 3-, and 6-months post-procedure using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS). Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.

This study aims to provide valuable insights into the comparative effectiveness and safety of CT-guided versus fluoroscopy-guided TG-RFT in managing idiopathic TN, potentially guiding future clinical practice.

Inclusion criteria

• Age >18 years
• Idiopathic trigeminal neuralgia (TN) based on the International Headache Society criteria
• Pain for at least six months and a NRS score greater than 6 despite medical treatment
• Able to provide informed consent.
• Agree to follow the study procedures and attend follow-up visits.

Exclusion criteria

• Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
• Trigeminal autonomic cephalalgias accompanied by autonomic symptoms
• 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
• Injection site or systemic infection
• Current participation in another clinical trial that could interfere with the outcomes of this study.