Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04684303
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-15
Brief Title:
EuroPainClinicsStudy XI Cryo vs RF MB Z Joints
Sponsor:
Europainclinics zú
Organization:
Europainclinics zú
Study Overview
Official Title:
EuroPainClinicsStudy XI Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
EPCS XI
Brief Summary:
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
Detailed Description:
Description of the clinical state
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas If this test is positive then the patients condition is indicated for radiofrequency ablation or cryoablation of the nerve branches
Description of interventional procedures
Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas If this test is positive then the patients condition is indicated for radiofrequency ablation or cryoablation of the nerve branches
Description of interventional procedures
Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging
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