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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, Justiz R, et al. 12-month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021. doi: 10.1111/papr.13066.