This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three-four days.
This investigation will be performed as a prospective, multicenter, open-label feasibility study. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three to four days. The investigational product for this feasibility trial will be the DISCSS™ system, not the commercially available trial SCS system. Exposure to the commercially available trial SCS system will be considered background therapy. The purpose of the background therapy phase is to establish baseline pain levels and determine patients' eligibility to continue to the investigational phase of the trial using the DISCSS™ SCS phase of the trial. Pain assessment and complications data from the commercial spinal stimulation system will be collected during the background therapy phase. The pain and complications data from the background therapy phase will not be analyzed in terms of the study endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of the current study.
Pain Treatment Centers
Ocala, Florida, United States
Sarasota Memorial Pain Care Center
Sarasota, Florida, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Neuromodulation Specialists, LLC
Pascagoula, Mississippi, United States
Change From Baseline (Day 1) to Visit 5 in Back Pain.
Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain).
Time frame: Baseline to visit 5
Incidence of Adverse Events
Incidence of adverse events arising from the DISCSS treatment phase
Time frame: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Patient Satisfaction
Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.
Time frame: Visit 5 (Day 10-11)
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Precision Spine Care
Tyler, Texas, United States