A new spinal cord stimulation system appears to markedly suppress pain caused by diabetic neuropathy, researchers reported at the 2021 virtual AAN Annual Meeting.
Patients diagnosed with diabetic neuropathy who were implanted with the 10 kilohertz spinal cord stimulation in the prospective, multicenter, randomized controlled trial (SENZA-PDN) reported that their pain scores decreased from a 7.6 cm on a visual analog scale to 1.7 cm at six months, reported Erika Petersen, MD, professor of neurological surgery and director of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences in Little Rock.
In the conventional medical management group of patients, the baseline pain level on the scale was 7.0 cm, but after six months the average pain score was 6.9 cm—demonstrating almost no difference, she noted.
“SENZA-PDN is the largest randomized clinical trial to date of 10 kHz spinal cord stimulation management of painful diabetic neuropathy," Dr. Petersen told Neurology Today At the Meetings. “Results through six months demonstrate substantial improvements for patients with refractory symptoms that exceed those seen with pharmacotherapy and low-frequency spinal cord stimulation."
“This study shows 10 kHz spinal cord stimulation provides profound, sustained pain relief, improves findings on neurological examination as well as patient-reported dysesthesias, and enhances quality of life," Dr. Petersen said. “For painful diabetic neuropathy patients with inadequate response to conservative care, 10 kHz spinal cord stimulation should be recommended as a treatment option."
“All patients originally randomized to 10 kHz stimulation have completed 12 months of follow up," Dr. Petersen said, “so we have demonstrated that the relief reported in our study after six months in the spinal cord stimulation arm is maintained at nine months and 12 months. Responder rates remain stable up to 12 months as well. The study will follow all patients out to 24 months to show durability of response."
Previously, she reported that the trial met its primary endpoint—the composite of 50 percent or greater pain relief without deterioration of neurological status at three months. Five percent of the 103 patients who were treated with conventional medical management met that endpoint compared with 86 percent of the 113 patients who were treated with spinal stimulation (p<0.001), Dr. Petersen said. The trial was sponsored by Nevro Corp. of Redwood City, CA.
Eligible patients had reported painful diabetic neuropathy for at least 12 months.
Dr. Petersen said there were two infections (2.2. percent) in patients that required device explant. Just 6.3 percent of conventional medical management subjects were deemed responders; 52 percent reported worsening pain, she reported in her poster presentation. In contrast, among patients who recede the implant, 85 percent were considered responders, and 2.3 percent reported worsening pain, she said.
“I would not consider spinal cord stimulation either a last resort or extreme," Dr. Petersen said. “It is a relatively low risk procedure to implant an epidural stimulator to affect spinal cord transmission of pain signals."
Commenting on the study, Chanë Price, MD, assistant professor of neurology at the University of Miami, said: “I use spinal cord stimulation for these patients after they have failed conservative treatment options. This is not a standard of care yet as many insurance carriers have not accepted this form of treatment for approval."
“Given the evidence from the most recent trials, this will soon be a standard of care, not only for painful diabetic neuropathy but also for other painful peripheral neuropathies such as chemotherapy-induced painful peripheral neuropathies," he said.
Dr. Petersen disclosed relationships with Abbott/St Jude Medical, Medtronic, Neuromodulation, Nevro, Vertos, Boston Scientific, Neuros Medical, ReNeuron, Saluda, and SynerFuse. Dr. Price had no disclosures.
AAN Abstract: Petersen E, Stauss T, Scowcroft J, et al. Sustained benefits for 10 kHZ spinal cord stimulation treatment of painful diabetic neuropathy—six month results from a multicenter randomized controlled trial.