Introduction: Spinal Cord Stimulation (SCS) is an established treatment for neuropathic pain. Advances in neuromodulation technologies have been hypothesized to improve historically challenging outcomes in patients with axial back pain (Deer et al., 2014). Recent developments include a 32-contact system utilizing anatomically-guided neural targeting. While retrospective clinical studies using this technology have demonstrated significant improvements in outcomes for patients with low back pain (Chafin et al., 2013; Hayek et al., 2014), prospective data is limited. To evaluate the effect of the programming features and lead options of an advanced SCS system on patient outcomes, the following study was designed and is underway.

Methods: A prospective, on-label, multi-center, blinded, cross-over, randomized controlled study (COVERAGE Study, Boston Scientific) will enroll up to 90 subjects at up to 10 US centers. Subjects are implanted with an SCS system with either a 32-contact surgical lead or 3-4 percutaneous leads. Each subject is followed up to 3-months post-IPG activation. After completion of the 3-month visit, subjects will continue to be followed for up to 36-months as part of the RELIEF Registry. The primary endpoint is the paresthesia coverage of targeted pain while minimizing unwanted paresthesia compared between an advanced programming algorithm and conventional programming. Additional study assessments include pain intensity, percent pain relief, perception and discomfort thresholds, and treatment satisfaction. Primary complaint of low back pain is one of the key inclusion criteria.

Results: The accompanying report describes the study design. Additionally, demographics, baseline characteristics, and other preliminary data are presented from 20 patients implanted with a 32-contact surgical lead.

Conclusions: The study evaluates the effects of advanced programming features, using newly available lead options, of a 32-contact SCS system on outcomes for patients suffering from low back pain. Additionally, study data enables examination of the subject cohort implanted with a novel 32-contact surgical lead.

Patient Care: To help provide patients with more options and customization when using SCS to treat pain.

Learning Objectives: 1. To evaluate the effect of the programming features of an advanced 32-contact SCS system on patient outcomes. 2. To evaluate the effect of lead options of an advanced 32-contact SCS system on patient outcomes. 3. To analyze preliminary data for a subset of subjects that were implanted with a novel 32-contact surgical lead.

References: 1. Deer T., et al., Neurostimulation for the treatment of axial back pain: a review of mechanisms, techniques, outcomes, and future advances. Neuromodulation. 2014. 17(2): p. 52-68. 2. Chafin, B., et al. (2013, December). Highly Significant Trial Outcomes with Precision Spectra and 16-contact Infinion Leads. Poster session presented at the meeting of the North American Neuromodulation Society, Las Vegas, NV, USA. 3. Hayek, S., et al. (2014, December). Long-Term Back Pain Relief with Precision Spectra SCS and 32-Contact Anatomically-Based Programming. Symposia presented at the meeting of the North American Neuromodulation Society, Las Vegas, NV, USA.