Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial

• Published in: Neuromodulation (Malden, Mass.) Vol. 26; no. 7; pp. 1400 - 1411
• Main Authors: Kapural, Leonardo, Patterson, Denis G., Li, Sean, Hatheway, John, Hunter, Corey, Rosen, Steven, Fishman, Michael, Gupta, Mayank, Sayed, Dawood, Christopher, Anne, Burgher, Abram, McJunkin, Tory, Ross, Edgar L., Provenzano, David, Amirdelfan, Kasra
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2023
• Subjects: Chronic pain; Chronic Pain - diagnosis; Chronic Pain - therapy; clinical trial; Humans; Leg; multiphase; Prospective Studies; remote monitoring; Single-Blind Method; Spinal Cord; spinal cord stimulation; Spinal Cord Stimulation - adverse effects; Spinal Cord Stimulation - methods; Treatment Outcome; clinical trial; remote monitoring; spinal cord stimulation; Chronic pain; multiphase
• ISSN: 1094-7159; 1525-1403
• DOI: 10.1016/j.neurom.2023.05.006

This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial. This 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. A 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. Multiphase 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. The Clinicaltrials.gov registration number for the study is NCT03594266.