Spinal cord stimulation provides pain relief in diabetic neuropathy
Presenter: Erika Petersen, MD, University of Arkansas in Little Rock, AK
10 kHz SCS Provides Durable Pain Relief and Neurological Improvements for Patients with Painful Diabetic Neuropathy: 24-Month RCT Results. Presented April 24, 2023.
About 25% of the 37 million Americans with diabetes have painful diabetic neuropathy. Conventional medical management, which includes pharmacotherapies, is ineffective for many patients. Spinal cord stimulation is an option that uses a device implanted under the skin that delivers electrical stimulation to the spinal cord to cut off pain signals to the brain, akin to a pacemaker for pain.
“Diabetic neuropathy often results in poor quality of life, depression, anxiety, and impaired sleep, and the available medications can be ineffective for many patients, or have side effects that patients cannot tolerate,” said lead author Erika Petersen, MD, of the University of Arkansas in Little Rock, AK. “Our results are exciting because there is an urgent need for more effective therapies.”
Peterson and colleagues conducted a prospective, multicenter, randomized, controlled trial of 216 patients who had painful diabetic neuropathy symptoms for at least 1 year and were refractory to medications. The patients had lower limb pain intensity of 5 cm or lower on the visual analog scale (scale 0-10 cm from low to high). Patients were randomized to 10 kHz spinal cord stimulation plus conventional medical management (103 patients) or conventional medical management alone (113 patients), with optional treatment crossover at 6 months. A total of 154 patients received an implant, and 142 patients continued on trial for 2 years.
At 6 months, 76% of patients who received spinal cord stimulation reported an improvement of 50% or more in their average pain relief. In comparison, patients who did not receive spinal cord stimulation reported a 2% increase in their average amount of pain. At 24 months, 90% of spinal cord stimulation recipients had a 50% or more improvement in average pain relief and 65% had profound pain relief, defined as 80% or more relief. “This shows that pain relief with spinal cord stimulation was durable,” Petersen said.
No patients who received spinal cord stimulation crossed over to conventional medical management at 6 months, while 93% of eligible patients assigned to conventional medical management elected to cross over to spinal cord stimulation.
In tests of motor function, sensation, and reflexes, at 6 months clinician-assessed neurological improvements were observed in 62% of patients in the spinal cord stimulation arm and 3% in the conventional medical management arm. Neurological improvements were also durable as 66% of patients receiving spinal cord stimulation had improvement at 24 months, said Petersen.
Spinal cord stimulation also led to a 66% average reduction in pain interference with sleep.
There were no device implant removals due to lack of efficacy. There were eight (5.2%) study-related infections, three that were resolved and five that required implant removal. This is within the range reported across all nondiabetic spinal cord stimulation patients (2.5%-10%), said Petersen.
In conclusion, Petersen said, “The results demonstrate that 10 kHz spinal cord stimulation offers a safe, effective, and durable treatment for refractory painful diabetic neuropathy with the potential to improve neurological function.”
She also noted that high-frequency stimulation appears to provide greater pain relief than low-frequency stimulation. High-frequency stimulation also does not create the “pins and needles” sensation that comes with low-frequency stimulation.
References
Petersen E, Stauss T, Scowcroft J, et al. 10 kHz SCS provides durable pain relief and neurological improvements for patients with painful diabetic neuropathy: 24 Month RCT results. Presented at the 75th Annual Meeting of the American Academy of Neurology, April 24, 2023.
Shillo P, Sloan G, Greig M, et al. Painful and painless diabetic neuropathies: What is the difference? Curr Diab Rep 2019; 19(6):32. doi:10.1007/s11892-019-1150-5.
Eldabe S, Buchser E, Duarte RV. Complications of spinal cord stimulation and peripheral nerve stimulation techniques: A review of the literature. Pain Med 2016; 17(2):325-36. doi:10.1093/pm/pnv025.
Disclosures
Erika Petersen
Consultant: Abbott, Biotronik, Medtronic, Nalu Medical, Nevro, Presidio Medical Center, Saluda Medical, and Vertos Medical.
Research Support: Mainstay Medical, Nalu Medical, Nevro, Saluda Medical, SPR Therapeutics
Stock Options: SynerFuse, neuro42
This study was funded by Nevro.