Background and Aims Spinal Cord Stimulation (SCS) is an established treatment indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs. Differential Target Multiplexed™ SCS is a proprietary therapy supported by preclinical and clinical research.1,2 In a recent Randomized Controlled Trial, DTM™ SCS demonstrated superior back pain relief to traditional SCS.2 To further tailor therapy delivery, DTM derivatives with reduced-energy profiles are being investigated.
Methods The DTM-LE SCS Study (NCT04601454) is an ongoing prospective, multi-center, open-label, post-market study to evaluate the efficacy of a DTM™ SCS derivative therapy. Primary inclusion criteria were patients indicated for SCS and overall pain Visual Analog Score (VAS) of ≥6 with moderate to severe back and leg pain.
Results Fifty-seven subjects (57.9% female) were enrolled and 43 completed trialing. Thirty-eight (38/43, 88.4%) had a successful trial period and 35 received a neurostimulator. At 3-months (n=32), the mean (%) change in overall VAS from baseline was -3.9 (-50.4%) and 75% of subjects reported satisfaction with the therapy. Furthermore, 68.8% of subjects improved to a less disabled category (Oswestry Disability Index) and 77.4% of subjects were in a better health state (EQ-5D). Outcomes from the 6-month visit will also be presented.
Conclusions Clinically meaningful pain relief, a high degree of therapy satisfaction, improved function, and improved quality of life were reported in this DTM™ SCS reduced-energy derivative study by patients with chronic back and leg pain.Energy conserving approaches have the potential to impact patient experience with both rechargeable and recharge-free devices.
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