Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Time Varied Pulse (TVP)-SCS settings
Denver Back Pain Specialists
Greenwood, Colorado, United States
RECRUITINGOrlando Health Neuroscience Institute
Clermont, Florida, United States
RECRUITINGOchsner Clinic Foundation
New Orleans, Louisiana, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGFox Chase Pain Management
Trevose, Pennsylvania, United States
RECRUITINGPCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
RECRUITINGInstitute of Precision Pain Medicine
Corpus Christi, Texas, United States
RECRUITINGTargeted Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Time frame: 3 months post-activation
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