Spinal Cord Stimulation for Predominant Low Back Pain

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