Actively Recruiting

Phase Not Applicable
All Genders
ID06779578

Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study Comparing Safety and Pain Relief

Led by Alexandria University · Updated on 2025-01-17

20

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating and comparing two types of pulsed radiofrequency ablation, bipolar and monopolar, in patients with medically refractory trigeminal neuralgia, a condition causing severe facial pain that has not responded to medication. This exploratory study involves patients diagnosed according to established criteria, with pain persisting above a certain level despite treatment, aiming to explore safety and effectiveness of these two procedures. Patients will be randomly assigned to receive either bipolar or monopolar pulsed radiofrequency ablation, both performed under fluoroscopic guidance with sedation and standard monitoring. The monopolar procedure uses a single radiofrequency cannula positioned near the trigeminal nerve, while the bipolar procedure involves two cannulas placed at specific locations. Both methods include sensory and motor testing to confirm placement, followed by pulsed radiofrequency treatment at controlled temperatures and durations. Participants will undergo pain assessments using a numerical rating scale at baseline and multiple follow-up points up to six months after treatment. Patient satisfaction will also be evaluated early after the procedure. The study will monitor the time to pain control, pain recurrence, medication needs, and any complications during or after the interventions. This comprehensive monitoring aims to capture treatment effects and safety over the study period.

CONDITIONS

Official Title

Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with classical trigeminal neuralgia according to International Classification of Headache Disorders (ICHD-3)
  • Patients with purely paroxysmal classical trigeminal neuralgia or with chronic pain
  • Patients with idiopathic trigeminal neuralgia involving V2 and/or V3 areas
  • Patients with brain MRI showing no structural cause for trigeminal pain
  • Patients with refractory trigeminal neuralgia pain persisting more than three months and scoring 5 or higher on pain scale despite medication
Not Eligible

You will not qualify if you...

  • Patients with painful trigeminal neuropathy as defined by ICHD-3
  • Patients with trigeminal neuralgia involving V1 area
  • Patients with trigeminal neuralgia combined with other unusual facial pain disorders
  • Patients with structural causes for trigeminal neuralgia such as vascular compression or tumors
  • Patients who have undergone previous radiofrequency procedures
  • Patients who refuse to participate in the study

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Alexandria University Faculty of Medicine

Alexandria, Egypt, 21517

Actively Recruiting

2

Cairo University Kasr Alainy Faculty of Medicine

Cairo, Egypt

Actively Recruiting

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Research Team

E

Eman Hamdy, PhD

A

Ahmed Elshal, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study Comparing Safety and Pain Relief | DecenTrialz