854-P: Global, Multicenter Registry of Prospectively-Enrolled Patients Utilizing SCS for Chronic Pain—Long-Term Outcomes from a Subcohort Diagnosed with Painful Diabetic Peripheral Neuropathy

Introduction & Objective: The American Diabetes Association recommends referring DPN patients to interventional pain management care when pharmacological therapies have no meaningful effect. Recent burgeoning of advances in neuromodulatory-based systems has thus spurred interest in re­assessing this patient population using implanted Spinal Cord Stimulation (SCS) devices. Here, we sought to assess real-world outcomes from a subset of those diagnosed with DPN as derived from a global, multicenter SCS patient registry.

Methods: RELIEF (NCT01719055) is a global, multicenter, prospective, single-arm, observational registry that collects real­-world data derived from the use of neurostimulation systems for chronic pain by patients within routine clinical practice. A sub-set of patients with a diagnosis of painful diabetic peripheral neuropathy were assessed for pain relief (e.g., Responder Rate [(% of patients reporting ≥50% targeted pain relief], Quality-of-Life [EQ-5D]), and Treatment Satisfaction [Patient Global Impression of Change, PGIC] and other relevant clinical measures, per standard of care.

Results: Forty-three patients were permanently device-implanted. Of those who reached their 12- (n=28), 24- (n=21) and 36-month (n=15) follow-up, treatment responder rates of 79%, 81%, and 73%, respectively, were observed. Furthermore, EQ-5D score increased 33% versus baseline (Δ0.17 EQ-5D index score) out to 36-months after implant, corresponding to a magnitude 3 times above the reported minimal clinically important difference. There was also a low rate of infection associated with the implant procedure of 4.7% (2/43).

Conclusion: The results of this sub-cohort assessment of RELIEF registry participants support use of SCS as a safe and effective treatment option in DPN-diagnosed patients with chronic pain who are nonresponsive to pharmacological-based therapies.