A Randomized Controlled Trial Evaluating DTM SCS for Intractable Chronic Low Back Pain with Leg Pain

Description

Synopsis

A multicenter, prospective, randomized controlled trial evaluated the effectiveness of differential target multiplexed SCS (DTM SCS) compared to traditional SCS during a 12-month period. Back pain responder rate (≥50% relief) of 80% with DTM SCS at the primary endpoint (3-month) was superior to the back pain responder rate of traditional SCS (51%). The response was sustained for 12 months (84% vs 51%). Furthermore, 69% of subjects receiving DTM SCS experienced profound back pain response (≥80% relief) compared to 35% of subjects receiving traditional SCS. Additional benefits were observed in quality of life, extent of disability, perceived improvement of change, and satisfaction.

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Disclosures

• MF: Consulting Fee from Abbott, Biotronik, Braeburn, Cornerloc, Medtronic, Nevro; Contracted Research with Abbott, Lumbrera, Medtronic, SGX Medical, Thermaquil; Ownership Interest at Celeri Health, Thermaquil.
• PSK: Consulting Fee from Biotronik; Speaker/Teacher with Medtronic.
  
• DP: Consulting Fee from Avanos, Boston Scientific, Esteve, Heron, Medtronic, Nevro; Contracted Research with Abbott, Avanos, Medtronic, Nevro.
• RV: Consulting Fee from Medtronic; Speakers Bureau with Medtronic; Ownership Interest at SGX Medical

Speaker(s):

• Michael Fishman, MD, MBA, Anesthesiologist and Interventional Pain Medicine Specialist, Center for Interventional Pain and Spine
• Dr. Harold J. Cordner, MD, Pain Medicine Specialist, Florida Pain Management Specialists
• Rafael Justiz, MD, Pain Medicine Specialist, Oklahoma Pain Physicians
• Dr. David Provenzano, MD, President, Pain Diagnostics and Interventional Care
• Dr. Binit Shah, MD, Pain Medicine Specialist, Carolinas Pain Center
• Christopher Merrell, MD, Interventional Pain Management Specialist, Low Country Orthopaedics
• Julian Naranjo, MD, Pain Medicine Specialist, South Florida Clincial Research
• Philip S. Kim, MD, Anesthesiologist and Interventional Pain Medicine Specialist, Center for Interventional Pain and Spine
• Dr. Aaron K. Calodney, MD, DABA, FASA, FIPP, ABIPP, Director of Clinical Research, Precision Spine Care
• Richard H. Bundschu, MD, Interventional Pain Management Specialist, Coastal Orthopedics and Sports Medicine
• Mahendra Sanapati, MD, Interventional Pain Management Specialist, Advanced Pain Care Clinics
• Vipul Mangal, MD, Pain Mangement Specialist, National Spine and Pain Centers
• Dr. Ricardo Vallejo, MD, PhD, Co-Founder, Director of Research, Millennium Pain Center
• Lachlan Davies, BSc, Sr. Clinical Research Manager, Evidence Strategy and Therapy Development, Medtronic
• David L. Cedeño, PhD, Researcher, SGX Medical