Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

NCT06684275 | Recruiting

• 1 other identifier: PRF-TRF-TN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia; Pulsed Radiofrequency; Thermal Radiofrequency; Neuropathic Pain; Facial Pain; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Medication Consumption

  12 weeks post-procedure

• Procedure-Related Adverse Events

  Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure

Study Arms (2)

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.

Procedure: Pulsed Radiofrequency (PRF)

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.

Procedure: Pulsed and Thermal Radiofrequency (PRF + TRF)

Interventions

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.

Pulsed Radiofrequency (PRF)

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.

Pulsed and Thermal Radiofrequency (PRF + TRF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia; Neuralgia; Facial Pain

Interventions

Pulsed Radiofrequency Treatment; Heart Rate; Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Ahmed A Bessar, MD, PhD

  Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Bessar, MD, PhD

CONTACT

+201000089595; Ahmedawadbessar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Model Details: Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 10, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)