Two-year SENZA-RCT results have been published in Neurosurgery, according to Nevro. The SENZA-RCT is a pivotal study that is both the largest prospective randomised clinical trial conducted in spinal cord stimulation history and the first to evaluate comparative effectiveness of spinal cord stimulation therapies.
The results demonstrate the sustained superiority of high-frequency 10 therapy versus traditional low-frequency spinal cord stimulation therapy across all primary and secondary endpoints. Significant findings from the SENZA-RCT study include:
- Superior back pain responder rate with high-frequency 10 therapy: 76.5% versus 49.3%; p<0.001
- Superior leg pain responder rate with high-frequency 10 therapy: 72.9% versus 49.3%; p=0.003
- Superior and durable pain relief with HF10 therapy: average VAS scores for back and leg pain of 2.4cm with high-frequency 10 therapy versus 4.5cm and 3.9cm with traditional spinal cord stimulation; p<0.001 and p=0.027
- HF10 therapy delivered pain relief with no paresthesia or paresthesia-related discomfort
- Consistent safety results with limited study-related serious adverse events in each treatment group at two years (5.0% for high-frequency 10 therapy, 7.2% for traditional spinal cord stimulation; p=0.56)
“More Americans are impacted by chronic pain than diabetes, heart disease and cancer combined and innovative, non-opioid treatments that work over a longer period of time are needed,” says Leo Kapural, the principal investigator of the study. “By demonstrating a significant and durable decrease in back and leg pain over a two-year period, Nevro’s high-frequency 10 therapy represents an important and evidence-based advance in pain medicine. As we read in the paper every day and hear mounting concern from regulatory agencies, treating chronic pain conditions with opioids is fraught with risks. High-frequency 10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients.”