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NCT04801407 Clinical Trial

Comparative Study inTreatment of Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:
Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04801407
Other study ID # Soh-Med-21-03-06
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date June 2022

Study information
Verified date March 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date June 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Failed medical treatment more than 6 months Exclusion Criteria: - Coagulation disorder or hemorrhagic disease; - Mental illness and inability to cooperate;

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Mohamed Abdelsamee Ahmed Sohag Sohag City

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Barrow Neurological Institute Pain Intensity Score 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). 3 months
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