Actively Recruiting
Comparison of Pulsed and Thermal Radiofrequency Treatments for Trigeminal Neuralgia A Randomized Controlled Trial Evaluating Pain Relief and Safety
Led by Zagazig University · Updated on 2024-12-31
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two treatments for adults with Trigeminal Neuralgia, a chronic condition causing severe facial pain. The study compares Pulsed Radiofrequency (PRF) alone with a combination of Pulsed and Thermal Radiofrequency (PRF + TRF) to determine which provides better long-term pain relief and reduces the need for pain medication. This randomized controlled trial focuses on adult patients experiencing significant facial pain that has not improved with medication. Participants will be randomly assigned to receive either PRF treatment, which uses electrical pulses to modulate nerve function without causing heat damage, or a combined PRF and Thermal Radiofrequency treatment that adds controlled heat to create a lesion on the trigeminal nerve. Both procedures are performed under sterile conditions with anesthesia, targeting the nerve responsible for the pain. The treatments aim to compare the pain relief and safety profiles of the two methods. During the 12-week follow-up, participants will have their pain levels assessed at baseline, 1 week, 4 weeks, and 12 weeks after the procedure using pain scales such as the Numeric Rating Scale and Visual Analog Scale. Researchers will also monitor changes in medication use and any adverse events related to the procedures. Participants will attend scheduled follow-up visits to support these assessments and ensure safety throughout the study period.
CONDITIONS
Official Title
Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-60 years
- Diagnosis of classical trigeminal neuralgia as defined by international criteria
- Unilateral, episodic facial pain lasting at least six months with a Numeric Rating Scale score greater than 6 despite medical treatment
- Ability to provide informed consent
- Willingness to follow study procedures and attend follow-up visits
You will not qualify if you...
- Secondary trigeminal neuralgia caused by tumors or multiple sclerosis
- Previous surgery or radiofrequency treatment for trigeminal neuralgia
- Pregnant or breastfeeding women
- Allergies to anesthetics or agents used in the procedure
- Significant psychiatric disorders affecting pain assessment or participation
- Coagulopathy or use of anticoagulants that prevent the procedure
AI-Screening
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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, MD, 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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