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.
Three-month outcomes (n=94) were assessed according to the following:
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 Included:
Additional secondary outcomes were also collected and evaluated and will be reported in the future. The frequency, type, seriousness and severity of adverse events, including study-related AEs, demonstrated a risk profile in line with SCS therapy.
NOTE: Subjects will continue to be followed in the Stimgenics DTM™ SCS RCT through 6- and 12-months post-implant. Data presented is from three months follow up.
DTM™ SCS demonstrated statically significant and superior back pain relief at 3 months (P= 0.0009) when compared to conventional SCS.
63% profound pain relief (≥ 80% reduction in pain) with DTM™ SCS
Data shows a 5.4 mean reduction in VAS at 3 months with DTM™ SCS from 7.26 at baseline to 1.88 at 3 months.
Data shows a 74% reduction in back pain at 3 months with DTM™ SCS compared with 46% for conventional SCS.
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