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
Authors: BERG ANTHONY , NOLES JOHN , LOUDERMILK ERIC , HEGARTY JOSEPH , HARRISON NATHAN , PHELPS JEFF B. , RAUCK RICHARD L. , PAEZ JULIO , LEE ALBERT , BOJRAB LOUIS , CID JOSE , PEREZ CONCEPCION , CHANDLER BRETT , SHAH BINIT , GUPTA MAYANK , TURLEY TODD , SANAPATI MAHENDRA , WILLOUGHBY CHANNING , THOMSON SIMON , SMITH STEPHEN G. , VARELA NICOLAS , CHRISTOPHER ANNE , CHEN LILLY , GOLDBERG EDWARD 
Published: June 2024

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.

Disclosure

A. Berg: Consultant; Boston Scientific Corporation. J. Noles: None. E. Loudermilk: Consultant; Boston Scientific Corporation. J. Hegarty: None. N. Harrison: None. J.B. Phelps: None. R.L. Rauck: Consultant; Boston Scientific Corporation. J. Paez: Consultant; Boston Scientific Corporation. A. Lee: None. L. Bojrab: None. J. Cid: None. C. Perez: None. B. Chandler: None. B. Shah: Consultant; Boston Scientific Corporation. M. Gupta: None. T. Turley: None. M. Sanapati: None. C. Willoughby: None. S. Thomson: Consultant; Boston Scientific Corporation, Mainstay Medical, Saluda Medical. S.G. Smith: None. N. Varela: None. A. Christopher: None. L. Chen: Consultant; Boston Scientific Corporation. E. Goldberg: Employee; Boston Scientific Corporation.

Funding

Boston Scientific Corporation