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NCT Number: NCT06684275

Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location status: Recruiting

Location contact

Ahmed A Bessar, MD, PhD

CONTACT

[email protected]

+201000089595

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Bessar, MD, PhD

CONTACT

[email protected]

+201000089595

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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