Remote SCS Management Reduces Patient Burdens and Improves Care: 12- month Study Results

Introduction: Most spinal cord stimulation (SCS) systems require frequent in-person visits for reprogramming, which may lead to extended wait times to optimize pain management1 and increased travel-related time/cost for patients.2 Recent technological advances enabling remote SCS device management may reduce patient burdens and increase healthcare efficiencies.3 BENEFIT-03 (NCT04683718) is an ongoing study of an SCS system with remote programming and automatic daily transmission of objective device monitoring data. In 2023, a protocol amendment increased the study size from 30 to 60 fully enrolled participants. We report preliminary 12-month results for this expanded cohort; final data analysis is planned for late-breaking presentation.

Methods: BENEFIT-03 is a prospective, multicenter, single-arm study ongoing in Australia with Human Research Ethics Committee approval in consenting participants with chronic low back and/or leg pain. Post-implant follow-up consists of in-office visits (up to 24 months) and remote visits initiated by participants, investigators, proactive triggers (based on automatic daily device monitoring), or patient-reported outcomes. Primary endpoints are responder rate (≥50% overall pain relief, VAS) and freedom from device-related complications at 6 months. Additional outcomes include use of remote management (i.e. remote monitoring/programming), participant and clinician experience, healthcare utilization, and travel burden.

Results: At time of analysis, 26 implanted participants had completed 12-month follow-up. Participants reported reductions in time/cost burdens: 96.2% agreed/strongly agreed that remote stimulator adjustments saved money (by reducing travel for office visits) and 92.3% agreed/strongly agreed remote follow-up provided more time for daily activities (by avoiding in-office reprogramming). Additionally, 92.3% agreed/strongly agreed they would choose a device with remote capabilities. Clinicians reported 96% of participants benefited from remote device management and clinic staff burdens were reduced in management of 72% of participants. Furthermore, clinicians estimated that remote management saved the top quarter of participants a mean of 9.2 visits from implant to month 12 (population mean: 3.3 visits saved). Saved visits avoided substantial travel time and cost, as participants reported mean round-trip travel of 285.5 km from home to clinic. Completion of 12-month follow-up for the expanded cohort is anticipated in time for late-breaking presentation of updated results.

Conclusion: Nearly all participants would choose a system with remote capabilities. Clinicians reported remote management benefited participants and reduced clinic staff burden. These results demonstrate proactive remote device management reduced participant in-office visit burden for SCS reprogramming, resulting in time and monetary savings. Planned analysis of complete 12-month follow-up data will provide important confirmation of long-term outcomes.