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 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 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