ABSTRACT
Introduction: Diabetic peripheral neuropathy (DPN) is the most common neuropathic syndrome seen in patients with diabetes. Roughly 30% of the diabetes patient population1 experience painful DPN symptoms including bilateral stabbing or burning pain in addition to numbness in the feet and lower legs. Traditionally painful DPN symptoms have been treated with conventional medical management (CMM) including glycemic control, general risk factor management, as well as pharmaceutical agents. These treatment approaches are often unsuccessful in the long-term1. Spinal cord stimulation (SCS) has been demonstrated as an effective treatment for painful DPN of the lower extremities with multiple publications dating back to 1996 showing benefits of SCS for pain relief and improved Quality of Life (QoL) in DPN patients (Figure 1)2-18. Method(s): A systematic literature review of the robust body of evidence for SCS in the treatment of painful DPN was conducted. Publications were selected for inclusion by two independent reviewers using defined selection criteria. Additional relevant publications from outside the search dates were included. Result(s): SCS was first documented as an effective treatment for DPN in three single-arm studies published between 1996 and 20122,4,5, one of which was followed-up to thirty-six months18, and another to seven-years3. These studies paved the way for two RCTs published in 20146,7, one of which was followed-up to five-years in two publications8,10, and another7 was followed-up with analyses on QoL9 and an evaluation of the effects of burst SCS17. Two meta-analyses were published in 2020 and 202111,12. A post-hoc analysis of a multi-center single-arm study on high frequency (10kHz) SCS to treat DPN was published in 202013 and followed by an RCT published in 202114 with additional 1-year follow-up15,16. Collectively these studies demonstrate that SCS is an effective therapy for patients with painful DPN by reducing pain and increasing QoL for DPN patients (Figure 1). Conclusion(s): This review of a large body of evidence shows a decades-long history of the effectiveness of SCS for symptom relief in patients suffering from painful DPN. Future research on the effectiveness of new waveforms and novel methods of energy delivery to the spinal cord are needed. The study of outcomes in addition to pain relief is also needed, which may better illustrate the breadth of effects of SCS therapy on the underlying disease factors. Increasing awareness of the current evidence is essential to increasing therapy adoption by expanding payer support and influencing referring health care provider behavior. Disclosure: Eric Grigsby, MD: AE Mann Foundation: Consulting Fee: Self, Bioness Inc.: Consulting Fee: Self, Medallion Therapeutics: Consulting Fee: Self, Medtronic: Consulting Fee: Self, SPR Therapeutics: Consultant: Self, Tenex Health: Consultant: Self, Voyager Therapeutics: Consultant: Self, Xalud: Consulting Fee: Self, AE Mann Foundation: Consulting Fee: Self, Medallion Therapeutics: Consulting Fee: Self, Bioness Inc.: N/A: Self, Medallion Therapeutics: N/A: Self, SPR Therapeutics: N/A: Self, Abbott / St. Jude Medical: N/A: Self, Tenex: N/A: Self, Vertos: N/A: Self, Xalud: N/A: Self, AE Mann Foundation: Consulting Fee: Self, Bioness Inc.: Consulting Fee: Self, Medtronic, Inc.: N/A: Self, Collegium Pharmaceutical, Inc.: Trustee: Self, Flowonix Medical: Served on speakers' bureau: Self, Jazz Pharmaceuticals: Served on speakers' bureau: Self, Jazz Pharmaceuticals: Trustee: Self, Spinal Restoration, Inc.: Trustee: Self, Jazz Pharmaceuticals: N/A: Self, Alfred Mann Foundation: N/A: Self, Boston Scientific: N/A: Self, CNS Therapeutics: N/A: Self, Collegium Pharmaceutical, Inc.: N/A: Self, Flowonix Medical: N/A: Self, Jazz Pharmaceuticals: N/A: Self, Medtronic, Inc.: N/A: Self, Myoscience: N/A: Self, NeurAxon Inc.: N/A: Self, Spinal Restoration, Inc.: N/A: Self, St. Jude Medical, Inc.: N/A: Self, Abbott Laboratories: Consultant: Self, Alfred Mann Foundation: Consulting Fee: Self, Cervel Neurotech, Inc.: Consultant: Self, CNS Therapeutics: Consultant: Self, Covidien: Consultant: Self, Cumberland Pharmaceuticals, Inc.: Consultant: Self, Flowonix Medical: Consultant: Self, Jazz Pharmaceuticals: Consultant: Self, Mainstay Medical: Consultant: Self, Medtronic, Inc.: Consultant: Self, Myoscience: Consultant: Self, NeuroPhage Pharmaceuticals: Consultant: Self, Nevro Corp: Consultant: Self, Palyon: Consultant: Self, Spinal Modulation: Consultant: Self, SPR Therapeutics: Consultant: Self, St. Jude Medical, Inc.: Consultant: Self, Tenex Health, Inc.: Consultant: Self, VertiFlex Inc.: Consultant: Self, Vertos Medical, Inc.: Consultant: Self, Xalud Therapeutics, Inc.: Contracted Research: Self, Medtronic, Inc.: Served on speakers' bureau: Self, Flowonix Medical: Served on advisory board: Self, Medtronic, Inc.: N/A: Self, Jazz Pharmaceuticals: N/A: Self, Medtronic, Inc.: Ownership Interest: Own Stock, Stock Options, Future Stock Options: Self, Nevro Corp: Ownership Interest: Own Stock, Stock Options, Future Stock Options: Self, Rachel Slangen, PhD: None, Lisa Johanek, PhD: Medtronic: Salary/Employee: Self, Maddie LaRue, PHD: Medtronic: Employee:, Cecile de Vos, PhD: None, Melissa Murphy: Medtronic: Consulting Fee:, Relievant: Consulting Fee:Copyright © 2023