Back to resultsComparative Study inTreatment of Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous radiofrequency trigeminal rhizotomy
Microvascular decompression of the trigeminal nerve
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring trigeminal neuralgia
Eligibility Criteria
Inclusion Criteria:
- Failed medical treatment more than 6 months
Exclusion Criteria:
- Coagulation disorder or hemorrhagic disease;
- Mental illness and inability to cooperate;
Sites / Locations
- Mohamed Abdelsamee Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
radiofrequency group
Microvascular decompression group
Arm Description
it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy
it is the group that will be treated with Microvascular decompression
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04801407
Brief Title
Comparative Study inTreatment of Trigeminal Neuralgia
Official Title
Comparative Study Between Microvascular Decompression and Percutaneous Radiofrequency Rhizotomy for Treatment of Trigeminal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
trigeminal neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective case -series hospital based study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiofrequency group
Arm Type
Active Comparator
Arm Description
it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy
Arm Title
Microvascular decompression group
Arm Type
Active Comparator
Arm Description
it is the group that will be treated with Microvascular decompression
Intervention Type
Procedure
Intervention Name(s)
percutaneous radiofrequency trigeminal rhizotomy
Intervention Description
percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and
Intervention Type
Procedure
Intervention Name(s)
Microvascular decompression of the trigeminal nerve
Intervention Description
Microvascular decompression is a procedure that decompress the nerve from vascular conflict
Primary Outcome Measure Information:
Title
Barrow Neurological Institute Pain Intensity Score
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Failed medical treatment more than 6 months
Exclusion Criteria:
Coagulation disorder or hemorrhagic disease;
Mental illness and inability to cooperate;
Facility Information:
Facility Name
Mohamed Abdelsamee Ahmed
City
Sohag
State/Province
Sohag City
ZIP/Postal Code
82514
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
roshdy elkhyat
Phone
+201223486390
Email
mohamedneurosurgery33@gmail.com
First Name & Middle Initial & Last Name & Degree
abdin khair-allah
Phone
+201020196831
Email
abdin_mail@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Comparative Study inTreatment of Trigeminal Neuralgia
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