Painful diabetic peripheral neuropathy (DPN) is treated medically with antineuralgics, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors which are often not satisfactory long-term. Spinal Cord Stimulation (SCS) is an effective treatment alternative per 3 randomized controlled trials (RCTs) which consistently demonstrate that SCS is more effective than conventional medical management for painful DPN treatment. To assess “real-world” SCS efficacy for painful DPN, we qualitatively looked for consistency in outcomes between published RCT results and patient-reported outcomes collected using a digital health platform. We retrospectively analyzed demographics and characterized pain profiles using PROMIS-29 (Patient-Reported Outcomes Measurement Information System®) surveys at baseline to 3-month follow-up. Between Oct-2022 and Jul-2023, 295 DPN patients underwent SCS device trials while using the digital health platform, with 69.2% receiving a permanent implant. At the time of submission, paired data at baseline and 3-mo was available for 20 patients. The data shows significant improvement in 6 of the 7 functional domains of the PROMIS-29 survey (Table 1). These findings suggest SCS can provide significant improvement in DPN pain-related symptoms. Collectively, robust published outcomes from 3 RCTs in combination with real-world data support the efficacy of SCS for painful DPN.
B.W. Bode: Research Support; Omnipod. Speaker's Bureau; Omnipod. Research Support; Medtronic. Advisory Panel; Medtronic. M. Murphy: Advisory Panel; Medtronic. Consultant; Relievant. R.A. Vigersky: Employee; Medtronic. L. Johanek: Employee; Medtronic. M. Martinez: Employee; Medtronic. A. Marquez: Employee; Medtronic. F. Coletti: Employee; Medtronic. M. LaRue: Employee; Medtronic.
This study was sponsored by Medtronic.