Medtronic plc today announced three-month results from a large, multicenter randomized controlled trial (RCT) showing statistically significant (p=0.0009) and superior back pain relief with Differential Target Multiplexed (DTM™) Spinal Cord Stimulation (SCS) compared to conventional SCS. Both arms used the Medtronic Intellis™ platform. Three-month results showed 80% of patients with chronic back pain treated with DTM reported at least 50% pain relief, compared with 51% of patients treated with conventional SCS, as measured by the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity. Fifty-percent pain relief, as measured by VAS, is a recognized industry standard to define minimum therapy success.
The RCT demonstrated profound pain relief and significant reductions in back and leg pain with DTM. Sixty-three percent patients with back pain treated with DTM reported profound pain relief of 80% or greater compared to 26% treated with conventional SCS. In aggregate, patients treated with DTM reported an average of 74% reduction in back pain compared to 46% with conventional SCS at three months. Similarly, improvements were observed with DTM for leg pain with a mean reduction of 72% compared to 59% with conventional SCS.
The RCT results reported are from 94 implanted SCS patients who were randomized to either the treatment or control arm and followed over the course of three months. With these results the study met its primary endpoint of noninferiority compared with conventional SCS, and a pre-specified secondary statistical test for superiority showing the difference between DTM and conventional SCS as highly significant. The study will continue to follow patients through 12 months post implant.
Medtronic acquired DTM therapy as part of its acquisition of Stimgenics announced in early January. DTM therapy, which was proven through the RCT only on the Medtronic Intellis platform, is a new and unique programming option available to treat patients with chronic pain that is based on years of preclinical research.
DTM therapy is the first tailored SCS approach intentionally developed from a novel scientific concept and demonstrated in an RCT. The study demonstrates that DTM therapy provides superior efficacy for patients with chronic back pain compared to conventional stimulation. Combined with Intellis, patients can access superior outcomes as demonstrated in the RCT on an unrivaled stimulation platform.”
Matt Thomas, vice president and general manager of the Stim and Early Interventions business, which is part of the Restorative Therapies Group at Medtronic
The DTM waveform may engage a novel mechanism that modulates both neurons and glial cells, expanding the understanding of SCS mechanisms of action. Glial cells outnumber neurons in the spinal cord by 12:1 and their role in pain have been explored in research for more than 20 years.
DTM has been studied in animal models, showing statistically significant reversal of pain behaviors compared to either low frequency or high frequency alone. In addition, preclinical studies investigating the genome of nerve-injured animals suggests that the DTM waveform has a greater impact in the neural-glial interaction than other frequencies. Basic science research is further expanding our understanding of SCS mechanisms of action. Glial cells are no longer thought to be only “glue” in the brain and spinal cord but active contributors to neural processing and various disease states including chronic pain.
Results from the RCT are being presented at the North American Neuromodulation Society (NANS) annual meeting Jan. 23-26, 2020 in Las Vegas and can also be found on the Medtronic website.