Conditions: Failed Back Surgery Syndrome Back Pain Pain in Leg, Unspecified
Keywords: FBSS post laminectomy syndrome SCS RCT back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 278
Healthy volunteers: no

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

Arms:
arm 1: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan arm 2: The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan

Interventions: intervention 1: Spinal Cord Stimulation (SCS) intervention 2: Optimal Medical Management (OMM)
Intervention descriptions: intervention 1: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group. intervention 2: The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

Protocol document: