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Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers

Primary Purpose

Trigeminal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
V2 thermal radio frequency
Sponsored by
Iraqi Board of medical specialties
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:above 40 severe pain normal neurological examination - Exclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry -

Sites / Locations

  • Mohammed Mahdi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

transcoronoid

infrazygomatic anterior out of plane

Arm Description

participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch

participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane

Outcomes

Primary Outcome Measures

1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection
new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No.

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
January 26, 2023
Sponsor
Iraqi Board of medical specialties
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1. Study Identification

Unique Protocol Identification Number
NCT05712993
Brief Title
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers
Official Title
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iraqi Board of medical specialties

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
new technique in targeting V2 under ultrasound guidance
Detailed Description
the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcoronoid
Arm Type
Experimental
Arm Description
participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch
Arm Title
infrazygomatic anterior out of plane
Arm Type
Experimental
Arm Description
participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane
Intervention Type
Procedure
Intervention Name(s)
V2 thermal radio frequency
Intervention Description
V2 targeted thermal radio frequency safely without sustained V3 stimulation
Primary Outcome Measure Information:
Title
1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection
Description
new method used to target V2 to decrease the chance of failure and to lessen the number of trials required the tools of measurement was the stimulation in volt and number of trial by No.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:above 40 severe pain normal neurological examination - Exclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry -
Facility Information:
Facility Name
Mohammed Mahdi
City
Baghdad
ZIP/Postal Code
10001
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
40 participants enrolled in the study complaining of sever TN with normal neurological examination

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Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers

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