Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia

Not Applicable

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Radiation: Gamma knife

• Registration Number: NCT03991039
• Lead Sponsor: University of Baghdad

Brief Summary

Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

Detailed Description

A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-15
• Study First Submitted QC: 2019-06-17
• Last Update Submitted: 2019-06-17
• Study First Posted: 2019-06-19
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• primary idiopathic trigeminal neuralgia

Exclusion Criteria

• secondary trigeminal neuralgia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVD Group	Gamma knife	Patients treated with microvascular decompression
Gamma knife group	Gamma knife	Patients selected to be treated with gamma knife radiosurgery

Primary Outcome Measures

Name	Time	Method
Barrow Neurological Institute Pain Intensity scale (1-5)	Two years	The pain evaluated pre- and post-operatively with the use of analgesic drugs the best is 1 indicates free of pain, the worst is 5. It is dependent score
visual analog scale (0-10)	Two years	Pain severity described subjectively by the patient himself pre and post treatment , the 0 is free of pain and worst is 10. It is dependent score
Brief Pain Inventory (1-7)	ُTwo years	Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score