High-frequency spinal cord stimulation relieved pain and improved sensation in painful diabetic neuropathy

Design

Multicentre randomised controlled trial, open-label for pain, blinded sensory and biopsy assessment

Population

91 adults with painful diabetic neuropathy on conventional medical management

Primary outcome

At least 50% lower-limb pain relief

Effect

27/34 with stimulation vs 2/50 with medical management (P<0.001); sensory improvement 55.2% vs 25.0% (P=0.01)

PDN-Sensory randomised 91 adults with painful diabetic neuropathy to conventional medical management alone or with 10-kHz spinal cord stimulation. Sensory scoring and skin biopsy nerve fibre counts were done by assessors blind to allocation; pain response was patient-reported and could not be blinded. The paper appeared in Diabetes Care on 9 September 2026.

In a worst-case modified intention-to-treat analysis, 27 of 34 patients who went on to a temporary stimulator trial reached at least 50% lower-limb pain relief, against 2 of 50 on medical management. At six months, a 3-point or greater fall in the modified Toronto Clinical Neuropathy Score occurred in 55.2% versus 25.0%, and lower-calf intraepidermal nerve fibre density rose by 0.58 fibres/mm versus a small fall. Eight of ten hierarchical secondary endpoints, including sleep and quality of life, were met.

The pain result repeats an earlier trial of the same device; the new element is the objective sensory and nerve fibre signal. That raises the idea of disease modification, but six months is short and the fibre change is modest.

In practice this is a referral option for patients whose pain persists after adequate trials of first-line agents, not a replacement for them. Availability and cost in India are major constraints, and access is largely limited to specialist pain centres.

• Consider pain-service referral when neuropathic pain persists despite adequate doses of two first-line agents
• Document a baseline pain score and a monofilament or vibration exam before referral, so response can be judged
• Explain that a temporary trial stimulator comes before any permanent implant
• Keep optimising glucose, foot care and first-line drugs alongside any device
• Warn patients that cost and access in India currently limit this to a few specialist centres

Why it matters

It is the first randomised hint that a neuropathy treatment might improve nerve function rather than just mask pain.

Don't overread it

Six months of nerve fibre data cannot show that stimulation slows or reverses neuropathy long term.

The statistics, in plain English

27 of 34 versus 2 of 50 is a very large difference in pain response, but the comparator was unblinded, so expectation may inflate it. The sensory and nerve fibre results were assessed blind, which makes them more credible, yet the 0.58 fibres/mm gain is small and was measured only at six months, among those with data.

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