Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283628
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-02-21
Brief Title:
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
LMB-RFA
Brief Summary:
The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch LMB nerve radio frequency ablation RFA will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation
Detailed Description:
To determine whether the parasagittal approach to lumbar medial branch LMB nerve radiofrequency ablation RFA will have greater efficacy than the traditional approach to lumbar medial branch nerve radiofrequency ablation
This will be accomplished by comparing the results between the newly proposed parasagittal approach and the traditional approach of medial branch RFA done on the same patient different sites with bilateral low back pain LBP
Traditional approach
The electrode is introduced at a 15-20 degrees ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process SAP and transverse process TP of the vertebral body to target the traversing medial branch nerve The reason for the proposed angle is to avoid the mamillo-accessory ligament MAL that may be ossified in up to 10 of the normal spine and in such cases potentially prevent proper coagulation of the medial branch nerve during the RFA procedure
Parasagittal new approach
Recently Tran et al showed that MAL is located more dorsally than it was thought earlier and therefore cant interfere with nerve coagulation during the RFA Consequently they proposed abandoning the 20-degree angle used for the traditional approach and placing the radiofrequency cannula parasagittally and more dorsally It is proposed that in order to achieve maximum nerve coagulation the electrode should be placed as parallel to the nerve as possible and placing it parasagittally helps achieve this goal The remainder of the procedure does not differ from the traditional method
This will be accomplished by comparing the results between the newly proposed parasagittal approach and the traditional approach of medial branch RFA done on the same patient different sites with bilateral low back pain LBP
Traditional approach
The electrode is introduced at a 15-20 degrees ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process SAP and transverse process TP of the vertebral body to target the traversing medial branch nerve The reason for the proposed angle is to avoid the mamillo-accessory ligament MAL that may be ossified in up to 10 of the normal spine and in such cases potentially prevent proper coagulation of the medial branch nerve during the RFA procedure
Parasagittal new approach
Recently Tran et al showed that MAL is located more dorsally than it was thought earlier and therefore cant interfere with nerve coagulation during the RFA Consequently they proposed abandoning the 20-degree angle used for the traditional approach and placing the radiofrequency cannula parasagittally and more dorsally It is proposed that in order to achieve maximum nerve coagulation the electrode should be placed as parallel to the nerve as possible and placing it parasagittally helps achieve this goal The remainder of the procedure does not differ from the traditional method
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