12-month Outcomes for Painful Diabetic Peripheral Neuropathy Patients Treated with SCS

Introduction: Multiple studies have demonstrated the benefit of spinal cord stimulation (SCS) for the treatment of painful Diabetic Peripheral Neuropathy (DPN) 1-2. Establishing a multidimensional view of patients in a real-world setting and understanding how reduced levels of pain improve multiple facets of patients' lives provides a more comprehensive view of the benefits of SCS therapy in this unique population.

Methods: SENSE SCS (Study to Evaluate Neuromodulation Subject Experience with Contemporary Spinal Cord Stimulation Modalities for Chronic Pain) is a prospective, hybrid decentralized, multi-center, post-market, non-randomized, observational clinical trial utilizing a custom built mobile application to collect electronic patient-reported functional outcomes3 and quality of life assessments including EQ-5D-5L, Patient Global Impression of Change (PGIC), and PROMIS-29. The study opened enrollment at ten sites across the United States. The study followed standard of care, enrolling subjects for on-label SCS indications prior to trial. Following successful trial, subjects are implanted with a commercially available Medtronic SCS systems (Vanta™, Intellis™ or Inceptiv™). Data presented here are a sub-analysis to characterize outcomes from Baseline, 1-, 3-, and 6-Month for subjects with a primary or secondary painful DPN indication. Final presentation will include 12-Month outcomes.

Results: Forty-two subjects with painful DPN were enrolled; Baseline characteristics are provided in Table 1. The majority of subjects are white (86%) males (62%) with an average age of 63 years. 55% have a primary indication of DPN and 79% have Type II Diabetes. PROMIS-29 data (Figure 1) shows improvement in all seven health domains, with the largest shift in percentage of subjects in the Normal/Mild range at 6-Month compared to Baseline in the domains of Pain Interference and Physical Function (21% to 71% and 0% to 57%, respectively). A clinically meaningful improvement (≥ 0.0744) in the EQ-5D-5L index value was achieved by 100% (12/12) of subjects at 6-Month (Figure 2). Further, at 3-Month 87% of subjects reported improvement in their condition and 78% of subjects indicated they would “probably” or “definitely” recommend the therapy (n=23). At Baseline, subjects had a mean Pain Intensity score of 7.2 (SD 1.6, n=29) which decreased to 3.9 (SD 2.8, n=14) at 6-Month (Figure 3).

Conclusion: These results demonstrate improvements in multiple assessments of functional outcomes, complementing the improvement observed in the pain intensity score for patients with painful DPN. These patient-reported outcomes support the importance of using multidimensional outcome measures when evaluating therapy success and patient well-being.