CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZagazig University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CT-guided Radiofrequency Thermocoagulation (RFT)
Procedure/SurgeryParticipants 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)
Procedure/SurgeryParticipants in this group will undergo fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (RFT). The procedure utilizes fluoroscopic imaging for needle placement and monitoring.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CT-guided RFTExperimental treatment 1 intervention
Group B: Fluoroscopy-guided RFTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.2
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.
Time frame
Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.Secondary outcomes
1
Medication Consumption
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.
Time frame
6 months post-procedure2
Procedure-related Adverse Events
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.
Time frame
Immediately post-procedure, 1 month, 3 months, and 6 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov