Comparison of the Radiofrequency Treatments for the Treatment of Trigeminal Neuralgia.
A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedStudy Start
First participant enrolled
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2023
CompletedSeptember 6, 2023
September 1, 2023
11 months
August 24, 2022
September 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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).
six months
Secondary Outcomes (2)
Numeric rating scale
baseline to six months
Patient satisfaction
six months
Study Arms (2)
Radiofrequency of peripheral branches of the trigeminal nerve
EXPERIMENTALpulsed radiofrequency treatment of the peripheral branches of the trigeminal nerve
Radiofrequency of gasserian ganglion
ACTIVE COMPARATORradiofrequency ablation of the gasserian ganglion
Interventions
radiofrequency ablation of the gasserian ganglion
radiofrequency of the peripheral trigeminal branches ( maxillary, mandibular, supraorbital)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 26, 2022
Study Start
August 25, 2022
Primary Completion
August 1, 2023
Study Completion
August 25, 2023
Last Updated
September 6, 2023
Record last verified: 2023-09