Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

December 29, 2024 updated by: Ahmed Awad Bessar, Zagazig University

Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Recruiting
        • Zagazig University, Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsed Radiofrequency (PRF)
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)
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.
Active Comparator: Pulsed and Thermal Radiofrequency (PRF + TRF)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief - Numeric Rating Scale (NRS)
Time Frame: 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.
Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Pain Relief - Visual Analog Scale (VAS)
Time Frame: 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.
Baseline, 1 week, 4 weeks, and 12 weeks post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Consumption
Time Frame: 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.
12 weeks post-procedure
Procedure-Related Adverse Events
Time Frame: 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.
Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Ahmed A Bessar, MD, PhD, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2024

Primary Completion (Estimated)

March 10, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 29, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF-TRF-TN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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