Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers

• Sponsor: Iraqi Board of medical specialties (Other)
• Overall Status: Completed
• CT.gov ID: NCT05712993
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

new technique in targeting V2 under ultrasound guidance

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Procedure: V2 thermal radio frequency	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Aug 20, 2022
• Actual Study Completion Date: Aug 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transcoronoid participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through coronoid notch	Procedure: V2 thermal radio frequency; V2 targeted thermal radio frequency safely without sustained V3 stimulation
Experimental: infrazygomatic anterior out of plane participants are TN patients complain TN without secondary causes of trigeminal neuralgia underwent V2 targeting through infrazygomatic anterior out of plane	Procedure: V2 thermal radio frequency; V2 targeted thermal radio frequency safely without sustained V3 stimulation

Outcome Measures

Primary Outcome Measures

1. 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 [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohammed Mahdi	Baghdad		Iraq	10001

Sponsors and Collaborators

• Iraqi Board of medical specialties

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iraqi Board of medical specialties
• ClinicalTrials.gov Identifier: NCT05712993
• Other Study ID Numbers: IraqBoard
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Trigeminal Neuralgia; Neuralgia

Study Results

No Results Posted as of Feb 6, 2023