Spinal Cord Stimulation Therapy Improves Quality of Life in Painful Diabetic Neuropathy

In the SENZA-PDN trial (NCT03228420), participants with painful diabetic neuropathy (PDN) who were treated with high-frequency (10 kHz) spinal cord stimulation (SCS) experienced pain relief and improved health-related quality of life (HRQoL), these data were published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes. 

"In addition to the strong clinical efficacy for HFX Therapy that has already been shown in our landmark SENZA-PDN trial, these results demonstrate improvement in several important health-related quality of life metrics in patients with PDN," said D. Keith Grossman, chairman, chief executive officer, and president of Nevro. "Coupled with previously reported data that showed substantial pain relief and neurologic improvements at 12 and 24 months, these data will be used to support physician referral decisions as well as our ongoing market access initiatives to expand payer coverage for this patient population."     

Compared with people who had conventional medical management, those who received SCS had significantly more pain relief. Participants also experienced better sleep, mood, and ability to carry out daily activities due to lower pain interference. At 12 months, participants treated SCS had HRQoL improvements that were 2.5- to 4.5-fold higher than the minimal clinically important difference. 

At 6 months, 74 of 87 participants who had SCS had at least a 50% reduction in pain vs 5 of 93 who had medical management, making the number-needed-to-treat (NNT) with SCS 1.3 (95% CI, 1.1-1.4) for 50% pain release. This suggest that for every 4 people with PDN treated with SCS, 3 will have at least a 50% reduction in pain. 

Over 70% of clinicians and patients reported patients were better or a great deal better than their preSCS baseline. The majority of participants (92%) were satisfied or very satisfied with the stimulation therapy. 

The SENZA-PDN study is the largest trial conducted to date for SCS treatment of PDN (n=216).