Comparing CT-guided and fluoroscopy-guided treatments for facial pain
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial
This study is testing whether CT-guided or fluoroscopy-guided treatments for facial pain can provide better relief and safety for adults with trigeminal neuralgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharqia Province) |
| Trial ID | NCT06620172 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of two methods of trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) for treating idiopathic trigeminal neuralgia in adults. Participants will be randomly assigned to receive either CT-guided or fluoroscopy-guided TG-RFT and will be monitored for pain relief, medication use, and any adverse events over a six-month period. The study seeks to determine if one method offers superior pain relief and safety compared to the other.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with idiopathic trigeminal neuralgia who have experienced significant pain for at least six months despite medical treatment.
Not a fit: Patients with secondary causes of trigeminal neuralgia, such as multiple sclerosis or those with certain medical conditions like coagulopathy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and safer treatment option for managing severe facial pain associated with idiopathic trigeminal neuralgia.
How similar studies have performed: While the specific comparison of CT-guided versus fluoroscopy-guided TG-RFT is novel, radiofrequency thermocoagulation has been established as a treatment for trigeminal neuralgia in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zagazig, Sharqia Province
- Zagazig University, Faculty of Medicine — Zagazig, Sharqia Province, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed A Bessar, MD, PhD — Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
- Study coordinator: Ahmed A Bessar, M.D., PhD
- Email: ahmedawadbessar@gmail.com
- Phone: 01000089595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.