Spinal cord stimulation eases pain and improves sensation in people with diabetic nerve damage

by Myra Wright, Wake Forest University School of Medicine

edited by Gaby Clark, reviewed by Andrew Zinin

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A multicenter randomized clinical trial led by researchers from the Pain Outcomes Lab at Wake Forest University School of Medicine found that high-frequency spinal cord stimulation significantly reduced pain and improved sensory function in people with treatment-resistant painful diabetic neuropathy. Researchers also observed early evidence of increased density of small nerve fibers in the skin, although more research is needed to understand their significance and whether they persist.

The findings were published today in Diabetes Care.

Diabetic neuropathy is a common complication of diabetes that can cause chronic pain, numbness and loss of feeling, particularly in the feet and legs. As nerve damage progresses, people may experience balance problems, foot ulcers and an increased risk of amputation. Available treatments primarily manage symptoms and do not reliably restore sensation or reverse established nerve damage.

How spinal cord stimulation works

The Painful Diabetic Neuropathy (PDN) Sensory study evaluated 10-kHz spinal cord stimulation, which involves surgically implanting thin leads near the spinal cord and a small pulse generator under the skin. The device sends mild electrical pulses that alter how pain signals travel to the brain without producing the tingling sensation associated with some older spinal cord stimulation systems.

"People with painful diabetic neuropathy often continue to struggle despite medications and other treatments," said Robert W. Hurley, M.D., Ph.D., corresponding author and professor of pain medicine and anesthesiology at Wake Forest University School of Medicine. "Many participants experienced substantial pain relief and improved sensory function, changes that may help them navigate daily activities more safely and comfortably."

Significant improvements in pain and sensation

The trial enrolled 91 adults with diabetes and chronic, treatment-resistant painful diabetic neuropathy at 13 centers across the United States. Participants were randomly assigned to receive either conventional medical management alone or spinal cord stimulation plus conventional medical management.

Over six months, researchers evaluated pain, sensory function, sleep, quality of life and other outcomes. Sensory testing and nerve-fiber measurements from skin biopsies were assessed by researchers who did not know which treatment participants received.

Using a conservative analysis that accounted for missing outcomes, 79.4% of participants who underwent temporary spinal cord stimulation achieved at least a 50% reduction in lower-limb pain, compared with 4% of participants receiving conventional medical management. Among those who received a permanent implant and completed six-month follow-up, 93.1% achieved at least a 50% reduction in pain.

The study also met its key sensory endpoint. Among participants who completed six-month follow-up, 55.2% of those receiving spinal cord stimulation experienced meaningful improvement in their ability to detect touch, temperature, vibration and body position, compared with 25% of those receiving conventional medical management. Participants receiving spinal cord stimulation also reported improvements in sleep and quality of life.

Early evidence of changes in nerve fibers

Skin biopsies showed an average 56% increase in small nerve-fiber density in the lower calf among participants receiving spinal cord stimulation, while no significant change was observed in the conventional treatment group.

The study was not designed to determine whether nerve fibers regenerated or whether the therapy alters the underlying progression of diabetic neuropathy.

"Pain relief was expected based on previous research, but the objective improvements in sensory measures and nerve-fiber density were particularly encouraging," Hurley said. "These findings suggest there may be effects beyond symptom control, although we need longer follow-up to determine whether the changes persist and what they mean for patients."

Study limitations and next steps

The researchers noted that participants knew which treatment they received, which may have influenced patient-reported outcomes, although the clinicians who collected patient data and assessed outcomes were blinded to treatment assignment. The trial was also stopped early after meeting its effectiveness criteria, which can make a treatment effect appear larger. In addition, participants primarily had severe, treatment-resistant neuropathy, so the findings may not apply to people with milder disease.

Participants will be followed for 12 months to determine whether the improvements in sensation and nerve-fiber density persist. Future studies will investigate the biological mechanisms that may underlie these changes.

Hurley served as principal investigator alongside co-investigators Janus Patel, M.D., and Daniel Bintrim, M.D., both assistant professors of pain and anesthesiology at Wake Forest University School of Medicine.

Publication details

Robert W. Hurley et al, Evaluating Improvement in Pain and Sensory Function When Using High-Frequency (10-kHz) Spinal Cord Stimulation in Individuals With Painful Diabetic Neuropathy: A Multicenter Randomized Controlled Trial (PDN-Sensory), Diabetes Care (2026). DOI: 10.2337/dc26-0758

Journal information: Diabetes Care

Clinical categories

NeurologyEndocrinologyCommon illnesses & Prevention Provided by Wake Forest University School of Medicine Who's behind this story?

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