CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
- Conditions
- Trigeminal NeuralgiaTrigeminal Neuralgia, Idiopathic
- Interventions
- Procedure: CT-guided Radiofrequency Thermocoagulation (RFT)Procedure: Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT)
- Registration Number
- NCT06620172
- Lead Sponsor
- Zagazig University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-guided RFT CT-guided Radiofrequency Thermocoagulation (RFT) Participants will undergo CT-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with real-time CT imaging for needle placement and monitoring. Fluoroscopy-guided RFT Fluoroscopy-guided Radiofrequency Thermocoagulation (RFT) Participants will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT) with fluoroscopic imaging for needle placement and monitoring.
- Primary Outcome Measures
Name Time Method Pain Relief - Numeric Rating Scale (NRS) 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.
Pain Relief - Visual Analog Scale (VAS) 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.
- Secondary Outcome Measures
Name Time Method Medication Consumption 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.
Procedure-related Adverse Events 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.
Trial Locations
- Locations (1)
Zagazig University, Faculty of Medicine
🇪🇬Zagazig, El-Sharkia, Egypt