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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: Irregular pulsed Radiofrequency; Procedure: Regular pulsed Radiofrequency

Detailed Description

Trigeminal neuralgia is a severe pain condition characterized by transient, paroxysmal, electric shock-like pain occurring in areas supplied by the trigeminal nerve. The incidence of trigeminal neuralgia increases with advancing age and has a substantial negative impact on quality of life, often leading to psychological distress.

Pharmacological therapy represents the primary treatment modality for most patients with trigeminal neuralgia. Surgical and interventional procedures, including microvascular decompression, partial sensory rhizotomy, radiofrequency therapy, glycerol rhizolysis, balloon compression, and gamma knife surgery, are generally reserved for patients who are resistant or intolerant to medical treatment. Each of these modalities has specific advantages and limitations, and no single ideal surgical treatment has been established.

Pulsed radiofrequency (PRF) is considered one of the least destructive neuromodulation techniques. It stimulates the gasserian ganglion using pulsed electrical current while maintaining tissue temperature below 42°C. The pulsed current is delivered intermittently, allowing heat dissipation and minimizing neural tissue damage. Patients who respond favorably to PRF often experience significant improvement in pain and quality of life; however, conventional PRF has been associated with limited efficacy and a shorter duration of pain relief compared to continuous radiofrequency techniques.

Several modifications have been introduced to enhance PRF effectiveness, including adjustments in output voltage and pulse delivery parameters. Despite these modifications, achieving an optimal balance between efficacy and safety remains challenging.

The Slijter-Teixeira Poisson (STP) mode of pulsed radiofrequency utilizes a Poisson distribution pattern for energy delivery, allowing pulses to be more evenly and precisely distributed. This approach aims to optimize therapeutic outcomes while minimizing heat generation and tissue injury. The STP mode provides shorter pulse widths and a higher coefficient of variance, which may enhance treatment effectiveness without increasing neurodestructive effects.

Accordingly, this study is designed to compare the efficacy and safety of regular pulsed radiofrequency and STP-mode pulsed radiofrequency applied to the gasserian ganglion in patients with primary trigeminal neuralgia.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Ahmed, assistant lecturer; Phone Number: 0201097988603; Email: ahmedmamdoh256789@gmail.com
• Study Contact Backup: Name: Ahmed M Elhalwagy, lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irregular pulsed radiofrequency STP group	Procedure: Irregular pulsed Radiofrequency; irregular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia
Active Comparator: Regular pulsed radiofrequency group	Procedure: Regular pulsed Radiofrequency; Regular pulsed radiofrequency applied to gasserian ganglion for primary trigeminal neuralgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Khaled A Mohamed, assistant professor, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: radiofreqency for treatment of trigeminal neuralgia
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Trigeminal Neuralgia
• Other Study ID Numbers: soh-Med-25-11-4MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No