Back Pain Clinical Trial
Official title:
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain
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).
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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