Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)

Inclusion Criteria

• Age greater than or equal to 18 years
• Able to understand the nature of the study and provide written informed consent
• Able to read, understand, and speak English
• Willing and able to comply with all study requirements, including all required procedures, phone calls and study visits
• Planned to undergo a commercial SCS trial of standard duration for the treatment of low back and/or leg pain with a commercially available SCS system as prescribed by a physician(s) according to FDA approved indications for use
• Planned utilization of preoperative antibiotics for SCS commercial trial
• Planned placement of two eight-electrode SCS trial leads (or at least one 16- electrode SCS trial lead) using a suitable technique for an extended trial (e.g. tunneling approach of a minimum of 3-4 cm, or buried lead trial) with at least one lead covering the T8 or T9 vertebral level
• Incoming Numerical Rating Scale (NRS) for pain (overall) of at least 6 (collected prior to the commercial trial)
• Passed psychological evaluation
• Negative MRSA screening result
• Negative MSSA screening result or documentation of subsequent decolonization routine if MSSA positive
• For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 7.5%

Exclusion Criteria

• Enrolled in any investigational SCS stimulation trial, for which the SCS system is not commercially available
• Presence of any life-threatening, underlying illness separate from their indication for SCS therapy
• Patients reporting pregnancy at the time of enrollment
• Patients with poor compliance for pain management regimen
• Patients currently involved in an active workers compensation claim and/or active litigation related to injury associated with indication for SCS
• Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to baseline data collection
• Patients with an implanted pacemaker, defibrillator, or other medical contraindications for SCS therapy
• Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator
• Patients immunocompromised and/or at high risk for infection
• Patients with morphine equivalent dose > 120 units
• Patients with documented history of allergic response or sensitivity to material(s) required for the study (e.g. silver impregnated antibacterial dressing, adhesives, titanium, silicone, etc.)
• Patients with a documented history of clostridium difficile