Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT01697358
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2012-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Spinal Cord Stimulation for Predominant Low Back Pain
Sponsor:
MedtronicNeuro
Organization:
Study Overview
Official Title:
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
Status:
COMPLETED
Status Verified Date:
2017-06
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:
PROMISE
Brief Summary:
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
Detailed Description:
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:
* SCS group (SCS+OMM)
* OMM group
* SCS group (SCS+OMM)
* OMM group
Study Oversight
Has Oversight DMC:
False
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?: