• Leonardo Kapural, Denis G Patterson, Sean Li, John Hatheway, Corey Hunter, Steven Rosen, Michael Fishman, Mayank Gupta, Dawood Sayed, Anne Christopher, Abram Burgher, Tory McJunkin, Edgar L Ross, David Provenzano, and Kasra Amirdelfan.
• Carolinas Pain Institute, Winston-Salem, NC, USA. Electronic address: lkapuralmd@gmail.com.
• Neuromodulation. 2023 Oct 1; 26 (7): 140014111400-1411.

ObjectiveThis study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.Materials And MethodsThis prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and baseline numerical rating scale (NRS) for overall pain intensity ≥6. After a successful commercial SCS trial, participants were randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B (approximately 300-600 Hz), delivered via an investigational external pulse generator and existing leads during an 11-to-12-day testing period. Primary end points were mean NRS change from baseline to final in-office visit for each multiphase therapy and between therapies. Secondary end points included mean NRS change from end of commercial trial to final study visit and incidence of device-related adverse events (AEs). Additional measures included patient-reported outcomes collected at home through electronic watches and written diaries. Power usage was compared between multiphase and commercial therapies.ResultsA total of 122 participants initiated a commercial trial; 77 were randomized to a multiphase arm, and 65 completed the study. Reductions in mean NRS scores from baseline to final study visit were significant for multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There was no statistically significant difference in mean NRS reduction or percent pain relief between multiphase therapies. In an additional analysis, 63.9% of participants reported greater pain relief with multiphase than with commercial SCS therapy in the at-home setting. On average, multiphase required less power than did commercial devices. One non-serious device-related AE was reported, and no infections occurred during the extended trial.ConclusionsMultiphase SCS effectively reduced pain in participants with chronic low back and/or leg pain during a trial, with no unanticipated device-related AEs reported. Future studies should evaluate long-term effectiveness of multiphase stimulation.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT03594266.Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

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