SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain With No Prior Surgeries

To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.

Key Inclusion Criteria:

• Chronic low back pain, with or without leg pain, for at least 6 months
• Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy)
• If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening
• Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

• Primary pain complaint of vascular origin (e.g. peripheral vascular disease)
• Require implantation of lead(s) in the cervical epidural space
• Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity
• Previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)