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CT-geleide versus fluoroscopiegeleide trigeminusganglion Radiofrequente thermocoagulatie voor idiopathische trigeminusneuralgie

18 september 2026 bijgewerkt door: Ahmed Awad Bessar, Zagazig University

CT-geleide versus fluoroscopiegeleide trigeminusganglion Radiofrequente thermocoagulatie voor idiopathische trigeminusneuralgie: een gerandomiseerde gecontroleerde studie

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Egypte
    • Sharqia Province
      • Zagazig, Sharqia Province, Egypte, 44519
        • Zagazig University, Faculty of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CT-guided RFT

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)

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.
Actieve vergelijker: Fluoroscopy-guided RFT

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Relief - Numeric Rating Scale (NRS)
Tijdsspanne: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.

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

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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Medication Consumption
Tijdsspanne: 6 months post-procedure

Changes in medication consumption will be assessed using the Medication Quantification Scale III (MQS III) at 6 months post-procedure. This measure will evaluate the impact of the interventions on the need for medications to manage trigeminal neuralgia.
6 months post-procedure
Procedure-related Adverse Events
Tijdsspanne: Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure

Adverse events related to the interventions will be systematically recorded to evaluate the safety profile of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT). Adverse events will be monitored and recorded immediately post-procedure and during follow-up visits at 1, 3, and 6 months.
Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Zagazig University

Onderzoekers

  • Hoofdonderzoeker: Ahmed A Bessar, MD, PhD, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 november 2024

Primaire voltooiing (Werkelijk)

10 mei 2025

Studie voltooiing (Werkelijk)

10 oktober 2025

Studieregistratiedata

Eerst ingediend

1 september 2024

Eerst ingediend dat voldeed aan de QC-criteria

29 september 2024

Eerst geplaatst (Werkelijk)

1 oktober 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

18 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TN_RFT

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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