Objective
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.

Materials and Methods
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.

Results
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.

Conclusions
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.

Clinical Trial Registration
The Clinicaltrials.gov registration number for the study is NCT03594266.

Direct Link: https://doi.org/10.1016/j.neurom.2023.05.006

Journal: Neuromodulation: Technology at the Neural Interface. 2023 Aug 16.

Keywords: Chronic pain, clinical trial, pain, Physical Activity, randomised controlled trial, remote monitoring, spinal cord injury, spinal cord stimulation,

Applications: Physical Activity,

CamNtech Reference: M23044

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