Comparative Study inTreatment of Trigeminal Neuralgia

March 15, 2021 updated by: mohmed abdelsamee ahmed, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Failed medical treatment more than 6 months

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: radiofrequency group
it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy
Procedure: percutaneous radiofrequency trigeminal rhizotomy
percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and
Active Comparator: Microvascular decompression group
it is the group that will be treated with Microvascular decompression
Procedure: Microvascular decompression of the trigeminal nerve
Microvascular decompression is a procedure that decompress the nerve from vascular conflict

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-03-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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