Trials Sponsors Conditions Drugs Pricing

Conditions

Trigeminal Neuralgia Trigeminal Neuralgia, Idiopathic

Keywords

CT-guided Radiofrequency ThermocoagulationFluoroscopy-guided Radiofrequency ThermocoagulationIdiopathic Trigeminal NeuralgiaPain ManagementInterventional 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.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age \>18 years
Idiopathic trigeminal neuralgia (TN) based on the International Headache Society criteria

Sponsors & Collaborators

Zagazig University
Governmentlead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

MeSH Terms

Conditions

Trigeminal NeuralgiaAgnosia

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Ahmed A Bessar, MD, PhD
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
PRINCIPAL INVESTIGATOR

Enrollment

68 participants (actual enrollment reported by the registry).

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

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

CT-guided RFT

Fluoroscopy-guided RFT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

CT-guided RFT

Fluoroscopy-guided RFT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations