High frequency stimulation of the spinal cord provides lasting pain relief for up to 12 months



The results of a randomized clinical trial presented at the 81st Scientific Sessions of the American Diabetes Association (ADA 2021) show that spinal cord stimulation resulted in lasting pain relief and improved quality of life over the course of a year.

In what investigators named the largest randomized clinical trial to evaluate spinal cord stimulation for the treatment of painful diabetic neuropathy, SENZA-PDN results show that the use of high frequency (10 kHz) spinal cord stimulation resulted in a reduction in reported pain and an improvement in Quality related to life expectancy compared to conventional medical treatment alone after 12 months.

“The 10 kHz spinal cord stimulation shows a lasting effect on pain that lasts for up to 12 months. We will continue our follow-up for up to 24 months with further analysis of health economic data and other indicators, ”said Erika Petersen, MD, director of the Functional and Restorative Neurosurgery Section at the University of Arkansas Medical School, during her presentation at the ADA 2021.

Because diabetic neuropathy is a difficult disease to treat in patients with diabetes, research has focused on identifying ways to mitigate the effects of diabetic neuropathy on the quality of life of patients with diabetes. With this in mind, SENZA-PDN was developed with the intention of assessing whether 10 kHz spinal cord stimulation can provide lasting, long-term pain relief without compromising the patient’s neurological health.

SENZA-PDN was funded by Nevro Corporation and included 216 patients who were randomized 1: 1 to either high rate spinal cord stimulation plus standard medical treatment or standard medical treatment alone. To be enrolled in the study, patients were required to have painful symptoms of diabetic neuropathy, lower limb pain of 5 cm or more on the VAS, and an HbA1c of 10% or more for 12 months or more. Results of interest included changes in pain, neurological function, and quality of life.

Ultimately, 113 patients were randomized to spinal cord stimulation and 103 to medical treatment alone. With 6 month data published in JAMA neurology, the ADA 2021 study detailed results from the 12-month analyzes of the study. It is noteworthy that patients who were randomly assigned to conventional medication treatment could decide to switch to alternative treatment after 6 months.

After 6 months, 82% of the patients assigned to conventional medical treatment decided to switch to the treatment arm of the study. Investigators indicated that no patient in the spinal cord stimulation group decided to switch to conventional medical treatment.

At 12 months, the results showed clear, sustained benefits of 10 kHz in terms of lower limb pain, pain interfering with daily life, quality of sleep, and activity. In addition, patients receiving spinal cord stimulation appear to have improvements in neurological function during exams. In safety analyzes, the researchers identified 5 cases of explants due to infection during the study.

“Interestingly, we found 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, entitled “Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial”, was presented at ADA 2021.



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