Spinal Cord Stimulation for Predominant Low Back Pain

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

Inclusion Criteria:

• SCS candidate with the Specify 5-6-5 surgical lead
• Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
• Average low back pain is ≥ 5 as assessed by the baseline NPRS
• Average low back pain is greater than leg pain
• Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion Criteria:

• Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
• Most recent back surgery < 6 months ago
• Low back pain only (no leg pain)
• Investigator suspects substance abuse that might confound the study results
• Radiographic evidence of instability requiring fusion
• Pain relieved completely by lying down
• Life expectancy of < 24 months
• Subject is pregnant or planning to become pregnant during the course of the study
• Subject is unable to undergo study assessments or complete questionnaires independently