According to the results, patients who received a SCS treatment along with CMM felt durable pain relief and significant improvements in both health-related quality of life and sleep at two years post-implantation
Two-year data released by Nevro supports its spinal cord stimulation treatment. (Credit: Towfiqu barbhuiya on Unsplash)
Nevro said that the 24-month data from the Senza painful diabetic neuropathy (PDN) trial showed that its spinal cord stimulation (SCS) reduced diabetic neuropathy pain.
The US-based medical device company published the study results in the Diabetes Research and Clinical Practice journal.
The SENZA-PDN randomized controlled trial (RCT) trial assessed the long-term efficacy of high-frequency 10 kHz SCS for the treatment of refractory PDN. It compared participants who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM) to CMM alone.
According to the results, patients who received a SCS treatment along with CMM felt durable pain relief and significant improvements in both health-related quality of life (HRQoL) and sleep at two years post-implantation.
Additionally, most patients reported improvements in neurological symptoms, encompassing improvements in motor skills, sensory perception, and reflex function.
The long-term data suggests that 10 kHz SCS is a safe, highly effective treatment for PDN and that it also improves the quality of life over the long run, the medical device firm claimed.
The trial’s lead principal investigator Erika Petersen said: “The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time.”
Furthermore, SCS lowered pain by a mean of 79.9% compared to baseline at two years. Nevro said that 90.1% of participants experienced ≥50% pain relief.
The investigators evaluated neurological function against the study baseline in all implanted patients. At the end of the study, 65.7% of implanted patients demonstrated clinically meaningful improvements over the study baseline.
The mean EuroQol 5-Dimensional 5-Level (EQ-5D-5L) index value increased by 0.146 before implantation to 24 months.
In addition, the baseline sleep quality was found to be poor among all participants, as confirmed by a mean score on the Pain and Sleep Questionnaire 3-Item Index of 6.5 cm at preimplantation.
The American firm said that the 24-month results were comparable with the six- and 12-month SENZA-PDN study outcomes.
Nevro chief medical officer David Caraway said: “Compared to previous studies evaluating traditional low-frequency systems for these patients, high-frequency 10 kHz SCS demonstrated greater pain reduction and higher responder rates over time.
“As we continue gathering data, we expect these results to be used in physician referral decisions and continue to support market access for high-frequency SCS for PDN patients.”