Actively Recruiting
Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
Led by Zagazig University · Updated on 2024-12-31
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 Pulsed Radiofrequency (PRF) compared to a combination of Pulsed and Thermal Radiofrequency (PRF + TRF) for treating adults with Trigeminal Neuralgia, a chronic condition causing intense facial pain. The study aims to find out which treatment provides better long-term pain relief and reduces the need for pain medication while monitoring complication rates. Participants will be randomly assigned to one of two groups. One group will receive PRF treatment targeting the trigeminal nerve using electrical pulses without causing thermal damage. The other group will receive PRF combined with thermal lesioning at 60-70°C to the nerve. Both procedures are performed under sterile conditions with monitoring and anesthesia. Participants will be followed for 12 weeks after treatment with assessments at 1, 4, and 12 weeks. Researchers will measure pain relief using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS), track changes in medication use, and record any procedure-related adverse events. This follow-up helps understand the treatments' effects on pain and safety over time.
CONDITIONS
Brief 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
- Diagnosed with classical trigeminal neuralgia according to International Classification of Headache Disorders
- Experiencing unilateral, episodic facial pain for at least six months with a Numeric Rating Scale (NRS) 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...
- Secondary trigeminal neuralgia (e.g., due to tumors or multiple sclerosis)
- Previous surgery or radiofrequency treatment for trigeminal neuralgia
- Pregnant or breastfeeding women
- Known allergies to anesthetics or agents used in the procedure
- Significant psychiatric disorders interfering with pain assessment or participation
- Coagulopathy or use of anticoagulants contraindicating the procedure
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.
Duration - Single procedure with immediate post-procedure monitoring
Participants receive either pulsed radiofrequency treatment or a combination of pulsed and thermal radiofrequency targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia.
1 procedure visit (in-person) and monitoring immediately after
Duration - 12 weeks
Participants are assessed for pain relief and procedure-related adverse events at multiple time points after treatment.
3 follow-up visits at Week 1, Week 4, and Week 12 (in-person)
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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