Trigeminal Neuralgia
Conditions
Keywords
Trigeminal Neuralgia, Pulsed Radiofrequency, Thermal Radiofrequency, Neuropathic Pain, Facial Pain, Radiofrequency Ablation
Brief 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.
Detailed description
This study is a randomized controlled trial designed to evaluate the efficacy and safety of Pulsed Radiofrequency (PRF) versus Pulsed and Thermal Radiofrequency (PRF + TRF) for treating Trigeminal Neuralgia (TN). Trigeminal neuralgia is a debilitating chronic pain condition that affects the trigeminal nerve, causing intense facial pain. The study will enroll participants with TN, randomized into two groups: * Group 1 (PRF): Patients will receive pulsed radiofrequency treatment with parameters set to standard levels for pain relief. * Group 2 (PRF + TRF): Patients will receive pulsed radiofrequency combined with thermal lesioning (60-70°C) to target the trigeminal nerve. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The primary outcome will be pain reduction measured using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) over a 12-week period. Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events. Participants will undergo follow-up assessments at Week 1, Week 4, and Week 12 post-treatment.
Interventions
PROCEDUREPulsed Radiofrequency (PRF)
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.
PROCEDUREPulsed and Thermal Radiofrequency (PRF + TRF)
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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
Intervention model description
Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief - Numeric Rating Scale (NRS) | Baseline, 1 week, 4 weeks, and 12 weeks post-procedure | 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. |
| Pain Relief - Visual Analog Scale (VAS) | Baseline, 1 week, 4 weeks, and 12 weeks post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Consumption | 12 weeks post-procedure | 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. |
| Procedure-Related Adverse Events | Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure | 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. |
Countries
Egypt
Contacts
Primary ContactAhmed A Bessar, MD, PhD
Outcome results
None listed