Comparative Study inTreatment of Trigeminal Neuralgia

Not Applicable

• Conditions: Trigeminal Neuralgia
• Interventions: Procedure: percutaneous radiofrequency trigeminal rhizotomy; Procedure: Microvascular decompression of the trigeminal nerve

• Registration Number: NCT04801407
• Lead Sponsor: Sohag University

Brief Summary

This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters.

Detailed Description

This is prospective case -series hospital based study, will be conducted on 40 patients with trigeminal neuralgia treated either by percutaneous radiofrequency trigeminal rhizotomy or microvascular decompression at Sohag University Hospitals, between march 2021 and June 2022 and we will divide the the patients into two groups ,one group will be treated with percutaneous radiofrequency trigeminal rhizotomy and the other group will be treated with microvascular decompression and we will asses the results with the Barrow Neurological Institute Pain Intensity Score .

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2022-05
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Failed medical treatment more than 6 months

Exclusion Criteria

• Coagulation disorder or hemorrhagic disease;
• Mental illness and inability to cooperate;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiofrequency group	percutaneous radiofrequency trigeminal rhizotomy	it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy
Microvascular decompression group	Microvascular decompression of the trigeminal nerve	it is the group that will be treated with Microvascular decompression

Primary Outcome Measures

Name	Time	Method
Barrow Neurological Institute Pain Intensity Score	3 months	I (no pain, no medication), II (occasional pain, not requiring medication), III (some pain, controlled with medication), IV (some pain, not controlled with medication) V (severe pain, no pain relief with medication).

Trial Locations

Locations (1)

Mohamed Abdelsamee Ahmed; 🇪🇬 Sohag, Sohag City, Egypt