Protocolized High-Dose (HD) and Low-Dose (LD) Spinal Cord Stimulation (SCS) Workflow Results in Meaningful Pain and Opiate Reduction

Abstract

INTRODUCTION: Various new waveforms for spinal cord stimulation (SCS) have emerged in recent years, with limited data supporting their utility in a real-world clinical setting.We report real-world results of a protocolized workflow algorithm that allows for high dose (HD) and low dose (LD) neurostimulation in patients with chronic pain undergoing SCS trial or permanent procedures. METHOD(S): Prospective data was collected using the Manage- MySurgery (MMS) mobile device platform in patients undergoing Medtronic SCS trial and permanent implant procedures. E-consent was obtained through the HIPAA compliant, mobile software platform. All data was de-identified, aggregated and analyzed. RESULT(S): In total, 104 patients (37 trial SCS and 67 permanent SCS) participated. For SCS trial and permanent procedures, the protocolized workflow algorithm resulted in a 91% trial success rate with >50% pain relief. At long-term follow-up (3 to 12 mo), 86% of permanent SCS patients reported they were getting the same or more relief as during their SCS trial. For permanent SCS patients, 79% reported >50% improvement in overall pain and 58% had >50% improvement in low back pain. The protocolized workflow algorithm resulted in a 37% "remitter rate," with these patients reporting themselves essentially pain free (VAS 0-3). Importantly, 52% of permanent implant patients stopped or reduced their 'as needed' painmedications by>50%. Additionally, 87% would recommend the same procedure to a friend or family member, 87% found device charging 'easy' or 'very easy' and 66% reported charging a few times a week or weekly. CONCLUSION(S): A protocolized workflow algorithm that allows for HDand LD neurostimulation appears to have robust utility in providing meaningful pain relief and opiate reduction during both the SCS trial and permanent stages and at longer-term follow-up. Randomized controlled trials with extended follow-up are in progress.