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B381 A modified energy DTM™ SCS therapy: 6-month outcomes of a prospective, multi-center study on patients with chronic back and leg pain
  1. J Peacock1,
  2. D Provenzano2,
  3. M Fishman3,
  4. K Amirdelfan4,
  5. T Bromberg5,
  6. T Schmidt6,
  7. T White7,
  8. P Grewal8,
  9. R Justiz9,
  10. A Calodney10,
  11. A El-Naggar11,
  12. B Shah12,
  13. M Esposito13,
  14. K Gatzinsky14,
  15. JW Kallewaard15,
  16. C Cain16,
  17. A Cleland16,
  18. M LaRue16,
  19. F Riillo16 and
  20. E Theis16
  1. 1Novant Health Spine Specialists, Winston-Salem, USA
  2. 2Pain Diagnostics and Interventional Care, Sewickley, USA
  3. 3Center for Interventional Pain and Spine, Lancaster, USA
  4. 4IPM Medical Group, Walnut Creek, USA
  5. 5Delaware Valley Pain and Spine Institute, Chalfont, USA
  6. 6Goodman Campbell Brain and Spine, Carmel, USA
  7. 7Sprintz Center for Pain, Shenandoah, USA
  8. 8TSAOG Orthopaedics and Spine, San Antonio, USA
  9. 9Oklahoma Pain Physicians, Norman, USA
  10. 10Precision Spine Care, Tyler, USA
  11. 11Drez One, LLC, Somerset, USA
  12. 12Carolinas Pain Center, Huntersville, USA
  13. 13Florida Pain Institute, Vero Beach, USA
  14. 14Sahlgrenska University Hospital, Department of Neurosurgery, Gothenburg, Sweden
  15. 15Rijnstate Hospital, Anesthesiology and Pain Medicine, Arnhem, Netherlands
  16. 16Medtronic, Minneapolis, USA


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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