Pulsed Radiofrequency Treatment Of the Gasserian Ganglion for tRigeminal nEuralgia: a retroSpective Study

Completed

• Conditions: Trigeminal Neuralgia (TN)
• Interventions: Procedure: PRF

• Registration Number: NCT06174818
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

With the Pulsed Radiofrequency treatment (PRF) Of the Gasserian ganglion for tRigeminal nEuralgia: a retroSpective Study (PROGRESS) the objective is to document the outcome of PRF (Pulsed Radiofrequency treatment) for patients with TN (Trigeminal Neuralgia), unresponsive to conservative treatment.

Detailed Description

Primary objective:

To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment)

Secondary objectives:

- To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score.

Study Timeline

• Study Start: 2022-04-17
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Study First Submitted: 2023-09-07
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Patients with trigeminal neuralgia who underwent their first PRF of the Gasserian ganglion between 01/09/2013 and 31/08/2021

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TN	PRF	Patients with trigeminal neuralgia

Primary Outcome Measures

Name	Time	Method
GPE <50%	Six weeks after treatment	To determine the proportion of patients in which PRF (pulsed radiofrequency) of the Gasserian ganglion for trigeminal neuralgia (TN) provides acute pain relief of at least 50% on the GPE (Global perceived effect) score (six weeks after treatment)

Secondary Outcome Measures

Name	Time	Method
Duration of GPE <50%	From six weeks post procedure until definitive or possible relapse of neuralgia, assessed up to 48 months.	To determine the duration during which PRF of the Gasserian ganglion for trigeminal neuralgia provides a reduction of at least 50% on the GPE (Grade Point Equivalent) score. This will be assessed six weeks post procedure and will be followed-up until definitive or possible relapse of neuralgia, assessed up to 48 months.

Trial Locations

Locations (1)

ZOL Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium