Efficacy and Safety of Irregular Pulsed Radiofrequency (Sluijter-Teixera Poisson) Versus Regular Pulsed Radiofrequency to the Gasserian Ganglion for Treatment of Primary Trigeminal Neuralgia

NCT07275229 | Not Yet Recruiting

• 1 other identifier: soh-Med-25-11-4MD
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare between the Efficacy and safety of irregular pulsed radiofrequency STP versus regular pulsed radiofrequency to the gasserian ganglion for treatment of primary trigeminal neuralgia.

Conditions

Trigeminal Neuralgia

Keywords

radiofreqency for treatment of trigeminal neuralgia

Outcome Measures

Primary Outcomes (1)

• change in pain intensity

  • Pain intensity of the attacks using VAS (''0'' no pain to ''10'' worst possible pain) day 1, after 1and 2 weeks and after 1,2,3 and 6 months. And dose of carbamazepine or oxcarbazepine will be recorded on day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure.

  day 1 after 1 and 2 weeks, and after 1, 2, 3 and 6 months following the procedure

Study Arms (2)

Irregular pulsed radiofrequency STP group

EXPERIMENTAL

Procedure: Irregular pulsed Radiofrequency

Regular pulsed radiofrequency group

ACTIVE COMPARATOR

Procedure: Regular pulsed Radiofrequency

Interventions

Regular pulsed Radiofrequency PROCEDURE

Regular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia

Regular pulsed radiofrequency group

Irregular pulsed Radiofrequency PROCEDURE

irregular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia

Irregular pulsed radiofrequency STP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
• Age between 18 and 75 years
• Severe trigeminal neuralgia not adequately relieved by conservative medical therapy, including carbamazepine or oxcarbazepine
• Numeric Rating Scale (NRS-11) pain score of 7 or higher prior to the procedure
• Ability and willingness to provide written informed consent

You may not qualify if:

• Secondary trigeminal neuralgia, including trigeminal neuralgia attributed to space-occupying lesions or multiple sclerosis
• Infection at the puncture site
• History of psychiatric disease
• Clinically significant abnormalities in routine laboratory tests, including hepatic, renal, or coagulation function, or abnormalities on electrocardiogram or chest X-ray
• Serious systemic diseases, including uncontrolled hypertension or diabetes mellitus, or cardiac dysfunction classified as New York Heart Association class II-III
• History of narcotic substance abuse
• Previous treatment with continuous radiofrequency to the gasserian ganglion or peripheral branches, glycerol rhizolysis, balloon compression, gamma knife surgery, or other neuroablative procedures
• Previous microvascular decompression

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Khaled A Mohamed, assistant professor

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Ahmed, assistant lecturer

CONTACT

0201097988603; ahmedmamdoh256789@gmail.com

Ahmed M Elhalwagy, lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12