351 Comparing SCS and Conventional Medical Management in Patients With No Prior Back Surgery (SOLIS RCT)

Abstract

INTRODUCTION: Spinal Cord Stimulation (SCS) as a treatment for chronic pain has been historically designated for patients who have had at least one prior spinal surgery. Modern SCS devices though now offer more novel technological capabilities and neurostimulative approaches than older-generational SCS systems. METHODS: This is a prospective, multicenter, randomized controlled trial (RCT) that compares therapeutic effectiveness of SCS versus CMM only, in patients with chronic low back and/or leg pain with no prior spinal surgery (SOLIS, Clinicaltrials.gov: NCT04676022). Enrolled NSBP patients are randomized to SCS combined with CMM (SCS + CMM arm) or a CMM-only arm. Those receving SCS are implanted with a multimodal system capable of engaging multiple mechanisms of action (Wavewriter Systems, Boston Scientific). Key inclusion criteria include diagnosis of chronic low back pain, with or without leg pain, for =6 months, and documented care of chronic pain for =90 days. The primary endpoint is responder rate (=50% reduction in pain) with no increase in baseline opioid medications to treat pain at 3-months following treatment activation. RESULTS: The primary endpoint (p < 0.0001) was met based on a prespecified cohort of 60 treatment-activated subjects. This analysis demonstrated that multimodal SCS combined with CMM was superior to CMM alone (p < 0.0001) in treating NSBP patients at 3-months follow-up (SCS: 88% versus CMM: 8%). Additionally, a 27-point reduction in Oswestry Disability Index score (improvement in disability) was noted in the SCS group versus a 6-point reduction in the CMM group. CONCLUSIONS: The data obtained in this RCT demonstrates that utilization of multimodal SCS provides for superior outcomes when compared to use of CMM alone for treatment of NSBP.