Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
Zagazig University
60 participants
Nov 10, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to compare the effectiveness of Pulsed Radiofrequency (PRF) with Pulsed and Thermal Radiofrequency (PRF + TRF) in treating Trigeminal Neuralgia (TN) in adults. The main questions it aims to answer are: * Does PRF or PRF + TRF provide better pain relief for patients with trigeminal neuralgia? * What is the safety profile and complication rate of PRF versus PRF + TRF? Researchers will compare the effects of PRF and PRF + TRF to see if thermal lesioning in addition to pulsed RF provides superior long-term pain relief and reduces the need for analgesic medication. Participants will: * Undergo either PRF or PRF + TRF treatment targeting the trigeminal nerve. * Be assessed for pain relief, functional status, and adverse events over a 3-month follow-up period.
Eligibility
Inclusion Criteria5
- Adults aged 18-60 years.
- Diagnosis of classical trigeminal neuralgia, as per the International Classification of Headache Disorders criteria
- Patients 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.
- Agree to follow the study procedures and attend follow-up visits.
Exclusion Criteria6
- Patients with secondary trigeminal neuralgia (e.g., due to tumors, multiple sclerosis).
- Previous surgery or radiofrequency treatment for trigeminal neuralgia.
- Pregnant or breastfeeding women.
- Known allergies to anesthetics or other agents used in the procedure.
- Significant psychiatric disorders that may interfere with pain assessment or study participation.
- Coagulopathy or use of anticoagulants that contraindicate the procedure.
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Interventions
Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion.
Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia.
Locations(1)
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NCT06684275