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

NCT06620172 | Recruiting

• 1 other identifier: TN_RFT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia; Trigeminal Neuralgia, Idiopathic

Keywords

CT-guided Radiofrequency Thermocoagulation; Fluoroscopy-guided Radiofrequency Thermocoagulation; Idiopathic Trigeminal Neuralgia; Pain Management; Interventional Pain Treatment

Outcome Measures

Primary Outcomes (2)

• Pain Relief - Numeric Rating Scale (NRS)

  The primary outcome measure will be the level of pain relief, as assessed by the Numeric Rating Scale (NRS), a 0-10 scale where 0 represents "no pain" and 10 represents "worst possible pain.". Pain levels will be recorded at baseline (pre-procedure), immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.

  Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.

• Pain Relief - Visual Analog Scale (VAS)

  Additionally, pain relief will be assessed by the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at the same time points: baseline, immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.

  Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.

Secondary Outcomes (2)

• Medication Consumption

  6 months post-procedure

• Procedure-related Adverse Events

  Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure

Study Arms (2)

CT-guided RFT

EXPERIMENTAL

Participants will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with real-time CT imaging for needle placement and monitoring.

Procedure: CT-guided Radiofrequency Thermocoagulation (RFT)

Fluoroscopy-guided RFT

ACTIVE COMPARATOR

Participants will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with fluoroscopic imaging for needle placement and monitoring.

Procedure: Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)

Interventions

CT-guided Radiofrequency Thermocoagulation (RFT) PROCEDURE

Participants in this group will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure involves real-time CT imaging to guide the placement of the needle and monitor the process.

CT-guided RFT

Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT) PROCEDURE

Participants in this group will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure utilizes fluoroscopic imaging for needle placement and monitoring.

Fluoroscopy-guided RFT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia; Agnosia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed A Bessar, MD, PhD

  Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Bessar, M.D., PhD

CONTACT

01000089595; ahmedawadbessar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: October 1, 2024
• Study Start: November 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 10, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)