Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
ConditionTrigeminal Neuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZagazig University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed Radiofrequency (PRF)
Procedure/SurgeryParticipants 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.
Pulsed and Thermal Radiofrequency (PRF + TRF)
Procedure/SurgeryParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Pulsed Radiofrequency (PRF)Experimental treatment 1 intervention
Group B: Pulsed and Thermal Radiofrequency (PRF + TRF)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Relief - Numeric Rating Scale (NRS)
The primary outcome measure will be the level of pain relief, assessed using the Numeric Rating Scale (NRS), a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Pain levels will be recorded at baseline (pre-procedure), and at 1 week, 4 weeks, and 12 weeks post-procedure.
Time frame
Baseline, 1 week, 4 weeks, and 12 weeks post-procedure2
Pain Relief - Visual Analog Scale (VAS)
Additionally, pain relief will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at baseline, 1 week, 4 weeks, and 12 weeks post-procedure.
Time frame
Baseline, 1 week, 4 weeks, and 12 weeks post-procedureSecondary outcomes
1
Medication Consumption
Changes in medication consumption will be assessed using the Medication Quantification Scale III (MQS III) at 12 weeks post-procedure. This measure evaluates the impact of the interventions on the need for medications to manage trigeminal neuralgia.
Time frame
12 weeks post-procedure2
Procedure-Related Adverse Events
Adverse events related to the interventions will be systematically recorded to evaluate the safety profile. Adverse events will be monitored and recorded immediately post-procedure and at follow-up visits at 1 week, 4 weeks, and 12 weeks post-procedure.
Time frame
Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedureSponsors and contacts
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Source ClinicalTrials.gov