Data from a RCT demonstrate the impact of high-frequency spinal cord stimulation on pain and quality of life among patients with a history of painful diabetic neuropathy lasting more than a year.
Results of a randomized clinical trial presented at the American Diabetes Association’s 81st Scientific Sessions (ADA 2021) demonstrate spinal cord stimulation provided durable pain relief and quality of life improvements over the course of a year.
In what investigators are calling the largest randomized clinical trial assessing spinal cord stimulation for management of painful diabetic neuropathy, results of SENZA-PDN indicate use of high-frequency (10 kHz) spinal cord stimulation was associated with reductions in reported pain and improvement in quality of life compared to conventional medical management alone at 12 months.
“10 kHz spinal cord stimulation shows a durable impact on pain maintained to 12 months. We will continue our follow-up up to 24 months with further evaluation of health economic data and other indicators,” said Erika Petersen, MD, Director of the Section of Functional and Restorative Neurosurgery at University of Arkansas Medical School, during her presentation at ADA 2021.
With diabetic neuropathy a difficult to treat condition among patients with diabetes, a research emphasis has been placed on identifying avenues of attenuating the impact diabetic neuropathy can have on the quality of life of patients with diabetes. With this in mind, SENZA-PDN was designed with the intent of assessing whether 10 kHz spinal cord stimulation could provide durable, long-term relief of pain without comprising neurological health of patients.
SENZA-PDN was funded by Nevro Corporation and enrolled 216 patients who underwent 1:1 randomization to either high-frequency spinal cord stimulation plus standard medical management or standard medical management alone. For inclusion in the study, patients needed to have painful diabetic neuropathy symptoms for 12 months or more, lower limb pain measured as 5 cm or more on the VAS, and an HbA1c of 10% or more. Outcomes of interest included changes in pain, neurological function, and quality of life.
Ultimately, 113 patients were randomized to spinal cord stimulation and 103 were randomized to medical management alone. With 6-month data published in JAMA Neurology, the ADA 2021 study detailed outcomes from the trial’s 12-month analyses. Of note, patients randomized to conventional medication management could opt to crossover to the alternative treatment after 6 months.
At 6 months, 82% of patients randomized to conventional medical management opted to cross over to the treatment arm of the trial. Investigators pointed out no patients in the spinal cord stimulation group opted to switch to conventional medical management.
At 12 months, results demonstrated clear, sustained benefits of 10kHz were observed in regard to lower limb pain, pain interference with daily living, sleep quality and activity. Additionally, patients receiving spinal cord stimulation appears to have improvements of neurological function during examinations. In safety analyses, investigators noted 5 instances of explantation due to infection occurred during the trial.
“Interestingly, we identified that neurological improvements were observed in many patients with 10 kHz stimulation although the mechanism of action is not understood,” added Petersen, during her presentation.
This study, “Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial,” was presented at ADA 2021.