Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06684275

Comparison of Pulsed and Thermal Radiofrequency Treatments for Trigeminal Neuralgia A Randomized Controlled Trial Evaluating Pain Relief and Safety

Led by Zagazig University · Updated on 2024-12-31

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two treatments for adults with Trigeminal Neuralgia, a chronic condition causing severe facial pain. The study compares Pulsed Radiofrequency (PRF) alone with a combination of Pulsed and Thermal Radiofrequency (PRF + TRF) to determine which provides better long-term pain relief and reduces the need for pain medication. This randomized controlled trial focuses on adult patients experiencing significant facial pain that has not improved with medication. Participants will be randomly assigned to receive either PRF treatment, which uses electrical pulses to modulate nerve function without causing heat damage, or a combined PRF and Thermal Radiofrequency treatment that adds controlled heat to create a lesion on the trigeminal nerve. Both procedures are performed under sterile conditions with anesthesia, targeting the nerve responsible for the pain. The treatments aim to compare the pain relief and safety profiles of the two methods. During the 12-week follow-up, participants will have their pain levels assessed at baseline, 1 week, 4 weeks, and 12 weeks after the procedure using pain scales such as the Numeric Rating Scale and Visual Analog Scale. Researchers will also monitor changes in medication use and any adverse events related to the procedures. Participants will attend scheduled follow-up visits to support these assessments and ensure safety throughout the study period.

CONDITIONS

Official Title

Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-60 years
  • Diagnosis of classical trigeminal neuralgia as defined by international criteria
  • Unilateral, episodic facial pain lasting at least six months with a Numeric Rating Scale score greater than 6 despite medical treatment
  • Ability to provide informed consent
  • Willingness to follow study procedures and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Secondary trigeminal neuralgia caused by tumors or multiple sclerosis
  • Previous surgery or radiofrequency treatment for trigeminal neuralgia
  • Pregnant or breastfeeding women
  • Allergies to anesthetics or agents used in the procedure
  • Significant psychiatric disorders affecting pain assessment or participation
  • Coagulopathy or use of anticoagulants that prevent the procedure

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zagazig University, Faculty of Medicine

Zagazig, Sharqia Province, Egypt, 44519

Actively Recruiting

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Research Team

A

Ahmed A Bessar, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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