Back to resultsGreater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine 1% Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal Neuralgia, Greater Occipital Nerve Block, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- Classical Trigeminal Neuralgia
Exclusion Criteria:
- Secondary Trigeminal Neuralgia
Sites / Locations
- Afyonkarahisar University of Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
%1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks
Outcomes
Primary Outcome Measures
Efficacy on pain severity
Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain
Efficacy on pain frequency
Pain frequency per day
Secondary Outcome Measures
Full Information
NCT ID
NCT04505280
First Posted
July 31, 2020
Last Updated
February 18, 2023
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04505280
Brief Title
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
Official Title
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to investigate the efficacy of greater occipital nerve block and cervical injections with lidocaine
Detailed Description
After being informed about the study and potantiel risks, all patients giving informed consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
Trigeminal Neuralgia, Greater Occipital Nerve Block, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
%1 lidocaine injections to greater occipital nerve and cervical region once a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% Injectable Solution
Intervention Description
Greater occipital nerve and cervical region injections once a week for 4 weeks
Primary Outcome Measure Information:
Title
Efficacy on pain severity
Description
Efficacy on pain scores. Visual Analogue Scale (VAS). VAS is a ten-point scale where zero refers to no pain and ten refers to maximal pain
Time Frame
3 months
Title
Efficacy on pain frequency
Description
Pain frequency per day
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Classical Trigeminal Neuralgia
Exclusion Criteria:
Secondary Trigeminal Neuralgia
Facility Information:
Facility Name
Afyonkarahisar University of Health Sciences
City
Afyonkarahisar
State/Province
Kartal/Soğanlık
ZIP/Postal Code
03217
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia
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