Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620172
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic Trigeminal Neuralgia A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the effectiveness and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation TG-RFT in treating idiopathic trigeminal neuralgia TN in adults aged 18 and older
The main questions it aims to answer are
Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT
What are the differences in medication consumption between the two methods
What are the procedure-related adverse events for both methods
Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN
Participants will
Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
Be monitored post-procedure and followed up at 1 3 and 6 months for pain relief medication consumption and adverse events
The main questions it aims to answer are
Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT
What are the differences in medication consumption between the two methods
What are the procedure-related adverse events for both methods
Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN
Participants will
Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
Be monitored post-procedure and followed up at 1 3 and 6 months for pain relief medication consumption and adverse events
Detailed Description:
This randomized controlled trial aims to compare the efficacy and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation TG-RFT in patients with idiopathic trigeminal neuralgia TN Idiopathic TN is characterized by severe recurrent facial pain and radiofrequency thermocoagulation is a common interventional treatment option
Participants eligible for this study will be adults over 18 years old diagnosed with idiopathic TN based on the International Headache Society criteria experiencing pain for at least six months with a numeric rating scale NRS score greater than 6 despite medical treatment
Exclusion criteria include vascular compression of the trigeminal nerve by MRI secondary causes such as multiple sclerosis trigeminal autonomic cephalalgias dental or temporomandibular joint pathologies previous interventional procedures or surgery for TN coagulopathy use of antiaggregants and anticoagulants cardiac pacemaker renal-hepatic insufficiency psychiatric illness malignancy or infection at the injection site or systemic infection
Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia The CT-guided RFT will use real-time CT imaging for needle placement and monitoring while the fluoroscopy-guided RFT will use fluoroscopic imaging
The primary outcome measure is pain relief assessed at 1- 3- and 6-months post-procedure using the Numeric Rating Scale NRS and Visual Analog Scale VAS Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III MQS III and the recording of procedure-related adverse events
This study aims to provide valuable insights into the comparative effectiveness and safety of CT-guided versus fluoroscopy-guided TG-RFT in managing idiopathic TN potentially guiding future clinical practice
Participants eligible for this study will be adults over 18 years old diagnosed with idiopathic TN based on the International Headache Society criteria experiencing pain for at least six months with a numeric rating scale NRS score greater than 6 despite medical treatment
Exclusion criteria include vascular compression of the trigeminal nerve by MRI secondary causes such as multiple sclerosis trigeminal autonomic cephalalgias dental or temporomandibular joint pathologies previous interventional procedures or surgery for TN coagulopathy use of antiaggregants and anticoagulants cardiac pacemaker renal-hepatic insufficiency psychiatric illness malignancy or infection at the injection site or systemic infection
Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia The CT-guided RFT will use real-time CT imaging for needle placement and monitoring while the fluoroscopy-guided RFT will use fluoroscopic imaging
The primary outcome measure is pain relief assessed at 1- 3- and 6-months post-procedure using the Numeric Rating Scale NRS and Visual Analog Scale VAS Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III MQS III and the recording of procedure-related adverse events
This study aims to provide valuable insights into the comparative effectiveness and safety of CT-guided versus fluoroscopy-guided TG-RFT in managing idiopathic TN potentially guiding future clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None