The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Hunter Pain Clinic
Newcastle, New South Wales, Australia
Pain Relief
Mean within-patient difference in average back pain intensity among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Pain Relief Responder Rate
Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Leg Pain Reduction
Mean within-patient difference in average leg pain intensity among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Disability
Mean within-patient difference in disability among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Percent Pain Relief
Mean within-patient difference in overall percent pain relief among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
Quality of Life, as Measured by EQ-5D-5L
Mean within-patient difference in quality of life among treatment groups
Time frame: 4,8,and 12 days post temporary lead(s) implantation
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