Clinical trial NCT06620172: CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
Official title: CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Trigeminal Neuralgia, Idiopathic
Keywords: CT-guided Radiofrequency Thermocoagulation
Fluoroscopy-guided Radiofrequency Thermocoagulation
Idiopathic Trigeminal Neuralgia
Pain Management
Interventional Pain Treatment
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating idiopathic trigeminal neuralgia (TN) in adults aged 18 and older.

The main questions it aims to answer are:

* Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT?
* What are the differences in medication consumption between the two methods?
* What are the procedure-related adverse events for both methods?

Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN.

Participants will:

* Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
* Be monitored post-procedure and followed up at 1, 3, and 6 months for pain relief, medication consumption, and adverse events.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Relief - Numeric Rating Scale (NRS)
timeFrame: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
measure: Pain Relief - Visual Analog Scale (VAS)
timeFrame: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
Secondary outcomes:
measure: Medication Consumption
timeFrame: 6 months post-procedure
measure: Procedure-related Adverse Events
timeFrame: Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
state: El-Sharkia
Study officials:
affiliation: Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
name: Ahmed A Bessar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: