Comparative Study inTreatment of Trigeminal Neuralgia

Overview

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.

Full Title of Study: “Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

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 .

Interventions

  • Procedure: percutaneous radiofrequency trigeminal rhizotomy
    • percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and
  • Procedure: Microvascular decompression of the trigeminal nerve
    • Microvascular decompression is a procedure that decompress the nerve from vascular conflict

Arms, Groups and Cohorts

  • Active Comparator: radiofrequency group
    • it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy
  • Active Comparator: Microvascular decompression group
    • it is the group that will be treated with Microvascular decompression

Clinical Trial Outcome Measures

Primary Measures

  • Barrow Neurological Institute Pain Intensity Score
    • Time Frame: 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).

Participating in This Clinical Trial

Inclusion Criteria

  • Failed medical treatment more than 6 months Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sohag University
  • Provider of Information About this Clinical Study
    • Principal Investigator: mohmed abdelsamee ahmed, assistant lecturer neurosurgery department – Sohag University

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