CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
NCT ID: NCT06620172
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-10
2025-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
NCT06684275
Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia
NCT06366139
Pulsed Radiofrequency in Trigeminal Neuralgia
NCT04355221
Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
NCT06779578
Comparative Study inTreatment of Trigeminal Neuralgia
NCT04801407
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CT-guided RFT
Participants will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with real-time CT imaging for needle placement and monitoring.
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.
Fluoroscopy-guided RFT
Participants will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with fluoroscopic imaging for needle placement and monitoring.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zagazig University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed A Bessar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TN_RFT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.