Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399841
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2006-11-13
Brief Title:
Spinal Cord Stimulation SCS for Neuropathic Pain of Back or Lower Extremity
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Spinal Cord Stimulation SCS for Neuropathic Pain of Back or Lower Extremity A Comparison of Electrode Placement at T7 and T8
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator Resigned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the efficacy and patient preference for spinal cord stimulation SCS using the Precision device with the electrode array placed at T7 versus placement at T8 Eligible patients will have chronic intractable pain in the back or lower extremities and will have independently elected SCS as the next line of therapy There is some anecdotal evidence that the coverage of the paresthesia resulting from T7 placement is preferable to that obtained by the more commonly used T8 placement but there has been no study to support this observation
Detailed Description:
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed at T8-T9 vertebral levels Recently published studies as outlined in a letter to the editor of Neuromodulation suggest that a well placed single lead will generally perform better than a dual lead Furthermore anecdotal reports suggest that lead placement at T7 will capture axial back pain with greater success compared to lead placement at alternative sites
This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7
This study aims to achieve better pain treatment and paresthesia coverage by placing a single lead at T7
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