Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366139
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
Trigeminal Ganglion RFT vs MaxillaryMandibular PRF in the Treatment of Trigeminal Neuralgia
Sponsor:
Diskapi Teaching and Research Hospital
Organization:
Diskapi Teaching and Research Hospital
Study Overview
Official Title:
Comparison of the Efficacy of Trigeminal Ganglion Radiofrequency Thermocoagulation and Ultrasound-guided Maxillary-mandibular Pulsed Radiofrequency in the Treatment of Trigeminal Neuralgia
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trigeminal ganglion TG radiofrequency thermocoagulation RFT and ultrasound US-guided maxillary or mandibular maxmand pulsed radiofrequency PRF are two interventional procedures for the treatment of trigeminal neuralgia TN The aim of this study was to compare the efficacy and safety of these two procedures For this evaluation the numeric rating scale NRS was used to assess pain relief and the Medication Quantification Scale III MQS III was used to assess the effectiveness of the interventions on medication consumption The rates of adverse events related to the interventions were also compared
Detailed Description:
Trigeminal neuralgia TN is a very severe unilateral short lightning-like pain that starts and ends suddenly and is limited to the areas related to the branches of the trigeminal nerve The pain can be triggered by stimuli such as washing face shaving smoking talking andor brushing teeth trigger factors and usually occurs spontaneously
Treatment of TN is complex despite the use of multiple medications and may be resistant Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular maxmand nerve PRF PRF delivers short bursts of high-voltage electrical current to the target nerve creating a non-thermal effect that modulates the transmission of pain signals RFT delivers a continuous current that heats the target tissue causing coagulation necrosis on nerves
Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN there is limited literature data on ultrasonography US-guided maxmand nerve PRF
The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and maxmand nerve PRF for TN Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events A total of at least 44 patients 22 patients in each group will be enrolled for comparison NRS and MQS III scores before treatments 1 month and 6 months after treatments will be compared both within and between groups
Treatment of TN is complex despite the use of multiple medications and may be resistant Interventional procedures are an option in cases that do not respond to medical treatments or if there are side effects Interventional procedures include trigeminal ganglion RFT and maxillary-mandibular maxmand nerve PRF PRF delivers short bursts of high-voltage electrical current to the target nerve creating a non-thermal effect that modulates the transmission of pain signals RFT delivers a continuous current that heats the target tissue causing coagulation necrosis on nerves
Although trigeminal ganglion RFT is a frequently performed method in the treatment of idiopathic TN there is limited literature data on ultrasonography US-guided maxmand nerve PRF
The primary aim of this study was to compare the efficacy of trigeminal ganglion RFT and maxmand nerve PRF for TN Secondary aims were to determine the effects of interventions on drug consumption and interventional safety based on adverse events A total of at least 44 patients 22 patients in each group will be enrolled for comparison NRS and MQS III scores before treatments 1 month and 6 months after treatments will be compared both within and between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None