Comparative Study inTreatment of Trigeminal Neuralgia

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04801407

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Procedure: percutaneous radiofrequency trigeminal rhizotomy Procedure: Microvascular decompression of the trigeminal nerve	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective case -series hospital based studyprospective case -series hospital based study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Barrow Neurological Institute Pain Intensity Score [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Failed medical treatment more than 6 months

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohamed Abdelsamee Ahmed	Sohag	Sohag City	Egypt	82514

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohmed abdelsamee ahmed, assistant lecturer neurosurgery department, Sohag University

ClinicalTrials.gov Identifier:

NCT04801407

Other Study ID Numbers:

Soh-Med-21-03-06

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mohmed abdelsamee ahmed, assistant lecturer neurosurgery department, Sohag University

trigeminal neuralgia

Additional relevant MeSH terms:

Trigeminal Neuralgia

Neuralgia

Study Results

No Results Posted as of Mar 17, 2021