Actively Recruiting
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial
Led by Zagazig University · Updated on 2024-11-12
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating adults aged 18 to 60 with idiopathic trigeminal neuralgia (TN). This condition involves severe, recurring facial pain, and the study aims to determine which imaging method provides better pain relief, affects medication use differently, and has fewer procedure-related side effects. Participants will be randomly assigned to receive either CT-guided TG-RFT, which uses real-time CT imaging to guide needle placement, or fluoroscopy-guided TG-RFT, which uses fluoroscopic imaging. Both procedures are done under sterile conditions with appropriate monitoring and anesthesia. After the procedure, participants will be followed for pain relief and side effects at 1, 3, and 6 months. During the study, participants will undergo pain assessments using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) at several time points including baseline, immediately after the procedure, and during follow-up visits. Medication use will be tracked at 6 months, and any procedure-related adverse events will be recorded throughout. The total involvement spans the procedure and follow-up assessments over six months.
CONDITIONS
Brief Title
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years and up to 60 years
- Diagnosis of idiopathic trigeminal neuralgia based on International Headache Society criteria
- Facial pain lasting at least six months with Numeric Rating Scale score greater than 6 despite medical treatment
- Able to provide informed consent
- Willing to follow study procedures and attend follow-up visits
You will not qualify if you...
- Vascular compression of the trigeminal nerve seen on MRI or angiography
- Secondary causes such as multiple sclerosis
- Trigeminal autonomic cephalalgias with autonomic symptoms
- Dental or temporomandibular joint disorders
- Previous interventional procedures or surgery for trigeminal neuralgia
- Coagulopathy or use of antiaggregants or anticoagulants
- Presence of cardiac pacemaker
- Kidney or liver failure
- Psychiatric illness diagnosis
- Malignancy
- Infection at injection site or systemic infection
- Participation in another clinical trial that may affect this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo trigeminal ganglion radiofrequency thermocoagulation guided either by CT imaging or fluoroscopy to treat idiopathic trigeminal neuralgia.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for pain relief, medication consumption, and any procedure-related adverse events after the treatment.
Visits at immediately post-procedure, 1 month, 3 months, and 6 months post-procedure
Trial Site Locations
Total: 1 location
1
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, Egypt, 44519
Actively Recruiting
Research Team
A
Ahmed A Bessar, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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