Comparative Study inTreatment of Trigeminal Neuralgia

NCT ID: NCT04801407

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-06-30

Brief Summary

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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

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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 .

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective case -series hospital based study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiofrequency group

it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy

Group Type ACTIVE_COMPARATOR

percutaneous radiofrequency trigeminal rhizotomy

Intervention Type PROCEDURE

percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and

Microvascular decompression group

it is the group that will be treated with Microvascular decompression

Group Type ACTIVE_COMPARATOR

Microvascular decompression of the trigeminal nerve

Intervention Type PROCEDURE

Microvascular decompression is a procedure that decompress the nerve from vascular conflict

Interventions

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percutaneous radiofrequency trigeminal rhizotomy

percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and

Intervention Type PROCEDURE

Microvascular decompression of the trigeminal nerve

Microvascular decompression is a procedure that decompress the nerve from vascular conflict

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Failed medical treatment more than 6 months

Exclusion Criteria

* Coagulation disorder or hemorrhagic disease;
* Mental illness and inability to cooperate;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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mohmed abdelsamee ahmed

assistant lecturer neurosurgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Abdelsamee Ahmed

Sohag, Sohag City, Egypt

Site Status

Countries

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Egypt

Facility Contacts

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roshdy elkhyat

Role: primary

+201223486390

abdin khair-allah

Role: backup

+201020196831

Other Identifiers

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Soh-Med-21-03-06

Identifier Type: -

Identifier Source: org_study_id

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