Three-year Outcomes of Spinal Cord Stimulation Across Multiple Indications: A Prospective, Global, Real-world Registry

Introduction: Chronic pain management remains a clinical challenge within various sub-populations such as those diagnosed with non-surgical refractory back pain (NSRBP), diabetic peripheral neuropathy (DPN), and Persistent Spinal Pain Syndrome Type II (PSPS2). As a non-opioid therapy, Spinal cord stimulation (SCS) offers the potential for treating chronic pain long term over several years. Here, we report data out to 3-years follow-up to show long-term outcomes in patients diagnosed with varying chronic pain indication.

Methods: Data for sub-cohort analyses were sourced from RELIEF (NCT01719055), a prospective, multicenter Spinal Cord Stimulation (SCS) outcomes registry. Sub-cohorts defined by a diagnosis of at least one of the following were assessed: NSRBP, DPN, PSPS2, or other. All patients were implanted with a multiple waveform enabled SCS system (Boston Scientific). Long-term pain relief outcomes as well as other measures such as responder rate (≥50% pain relief) , treatment satisfaction (Global Impression of Change), quality of life (EQ-5D-%L) are assessed out to 3-years follow-up.

Results: To date, approximately 1,163 subjects have completed their 1-year visit, with approximately 380 completing their 3-year visit. In the sub-cohort of NSRBP patients (n =108), SCS demonstrated a durable responder rate of ≥75% defined sustained for up to three years following implantation. Patient-reported satisfaction was notably high, with 85% indicating improvement ranging from minimal to very much improved. In the diabetic peripheral neuropathy (DPN) cohort (n =43), ≥73% of patients achieved at least 50% pain relief at up to 3-years follow-up. Furthermore, improvement in mean quality of life was 3 times the minimally importance difference (MID) previously established within the Type 2 Diabetic population (1). In addition, ≥80% within the DPN subgroup reported treatment satisfaction out to 3-years follow-up. Additional analyses within other sub-groups (e.g., PSPS2) are currently underway and a fully updated dataset will be reported.

Conclusion: These real-world findings underscore the long-term effectiveness of spinal cord stimulation (SCS) in delivering sustained, clinically meaningful pain relief and high patient satisfaction across diverse chronic pain populations. With durable outcomes to three years post-implantation, the data reinforces SCS as a viable therapeutic option capable of maintaining its benefits over time. This evidence strengthens the case for SCS not just as a short-term intervention, but as a reliable, long-term solution for managing chronic pain.