This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
211
Senza 10 kHz Spinal Cord Stimulation
Conventional Medical Management
Nevro Corp
Redwood City, California, United States
Difference between treatment groups in responder rates.
Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS)
Time frame: 3 Months
Change in Disability as Measured by Oswestry Disability Index
Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score
Time frame: 6 months
Percentage change from baseline in back pain intensity (as assessed by VAS)
Time frame: 6 months
Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire
It measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. In addition there is an EQ VAS which records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value".
Time frame: 6 months
Global impression of change
Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire
Time frame: 6 months
Change from baseline in opioid equivalent medication usage in each group
Time frame: 6 months
Neurological assessment
Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status.
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Time frame: 3, 6 and 12 months
Incidences of adverse events
Time frame: 3, 6 and 12 months