The DTM™ Spinal Cord Stimulation (SCS) RCT is a prospective, post market, multicenter, randomized control trial comparing the efficacy of DTM™ SCS for back pain compared to conventional SCS. Both therapies were evaluated using the Intellis™ neurostimulator.
Primary Objective: The effectiveness of DTM™ SCS in reducing back pain as compared to conventional SCS for the treatment of chronic, intractable back pain measured by the percentage of responders (≥50% reduction in pain) at three months post device activation.
Secondary Objectives evaluated through 12 months:
Descriptive comparison including studies with similar design (RCT; randomization >100 subjects; comparing two SCS therapies; with at least 12-Months follow up) and patient populations (inclusion/exclusion criteria; baseline demographics) with back pain responder rates reported. This is not based on a statistical analysis of outcomes between studies.
Sustained back pain relief with a mean VAS score less than 2 at 12 months.
Sustained leg pain relief with a mean VAS score less than 2 at 12 months.
Fishman M, Cordner H, et al. DTM™ SCS RCT 12-month data results. Presented at a Medtronic webinar, jointly supported by the North American Neuromodulation Society (NANS), World Institute of Pain (WIP), and the American Society for Pain and Neuroscience (ASPN). October 19, 2020. Webinar available on society websites.