Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
Primary Purpose
Trigeminal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
radiofrequency of gasserian ganglion
radiofrequency of the peripheral trigeminal branches
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
- Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
- Agree to participate in the study
Exclusion Criteria:
- Infection at the puncture site.
- Coagulation disorder.
- Abnormal blood test (hepatic or renal function)
- History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
Sites / Locations
- Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiofrequency of peripheral branches of the trigeminal nerve
Radiofrequency of gasserian ganglion
Arm Description
pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve
radiofrequency ablation of the gasserian ganglion
Outcomes
Primary Outcome Measures
The modified Barrow Neurological Institute Pain Intensity Score
The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).
Secondary Outcome Measures
Numeric rating scale
Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Patient satisfaction
Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)
Full Information
NCT ID
NCT05516888
First Posted
August 24, 2022
Last Updated
September 3, 2023
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05516888
Brief Title
Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
Official Title
A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
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
The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.
Detailed Description
Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.
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
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency of peripheral branches of the trigeminal nerve
Arm Type
Experimental
Arm Description
pulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve
Arm Title
Radiofrequency of gasserian ganglion
Arm Type
Active Comparator
Arm Description
radiofrequency ablation of the gasserian ganglion
Intervention Type
Procedure
Intervention Name(s)
radiofrequency of gasserian ganglion
Intervention Description
radiofrequency ablation of the gasserian ganglion
Intervention Type
Procedure
Intervention Name(s)
radiofrequency of the peripheral trigeminal branches
Intervention Description
radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)
Primary Outcome Measure Information:
Title
The modified Barrow Neurological Institute Pain Intensity Score
Description
The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).
Time Frame
six months
Secondary Outcome Measure Information:
Title
Numeric rating scale
Description
Pain will evaluated by a numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Time Frame
baseline to six months
Title
Patient satisfaction
Description
Patient satisfaction scores on the 5-point Likert scale (1: poor, 2: fair, 3: good, 4: very good, 5: excellent)
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
Agree to participate in the study
Exclusion Criteria:
Infection at the puncture site.
Coagulation disorder.
Abnormal blood test (hepatic or renal function)
History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
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Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
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