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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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Radiofrequency (PRF) | Experimental | Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol. |
|
| Pulsed and Thermal Radiofrequency (PRF + TRF) | Active Comparator | Participants in this group will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF). The TRF procedure will involve creating a thermal lesion at a target temperature in addition to the standard PRF treatment protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Radiofrequency (PRF) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 week, 4 weeks, and 12 weeks post-procedure |
| 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. | Baseline, 1 week, 4 weeks, and 12 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks post-procedure |
| Procedure-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Bessar, MD, PhD | Contact | +201000089595 | Ahmedawadbessar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Bessar, MD, PhD | Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University, Faculty of Medicine | Recruiting | Zagazig | Sharqia Province | 44519 | Egypt |
At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D009437 | Neuralgia |
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| D006339 | Heart Rate |
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
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Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)
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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.
|
| Pulsed and Thermal Radiofrequency (PRF + TRF) | Procedure | 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. |
|
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. |
| Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |