To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
To receive Spinal Cord Stimulation programming
To receive conventional medical management
Vitamed Research
Palm Desert, California, United States
Responder Rate
Proportion of subjects with 50% or greater reduction in overall pain relief
Time frame: 3 months post-activation
Change in Disability (Oswestry Disability Index)
Change in Disability (Oswestry Disability Index). The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Time frame: 3-Months post activation
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