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).

In 30 seconds

The multicenter randomized controlled PDN-Sensory trial evaluated 10-kHz spinal cord stimulation (SCS) plus conventional medical management (CMM) versus CMM alone in people with painful diabetic neuropathy. Among 91 randomized participants, 27 of 34 who underwent a temporary SCS trial achieved at least 50% lower-limb pain relief, compared with 2 of 50 receiving CMM alone (P < 0.001). At 6 months, sensory improvement was also more frequent with SCS, and lower-calf intraepidermal nerve fiber density increased relative to CMM alone. The findings suggest benefit, while longer-term confirmation is needed.

Key findings

• Pain response occurred in 27 of 34 participants who underwent a temporary SCS trial versus 2 of 50 receiving CMM alone (P < 0.001).
• At 6 months, mTCNS sensory improvement occurred in 16 of 29 (55.2%) SCS participants versus 12 of 48 (25.0%) CMM-alone participants (P = 0.01).
• Mean lower-calf IENFD change was 0.58 fibers/mm with SCS versus -0.07 with CMM alone (P = 0.03).
• Eight of 10 hierarchical secondary end points, including sleep and quality of life, were met.

Why it matters

The trial reports improvements not only in pain but also in prespecified sensory measures and a nerve-fiber-density measure. These outcomes broaden the evidence beyond symptom relief and may inform assessment of 10-kHz SCS in painful diabetic neuropathy. However, the authors describe the findings as consistent with a potential disease-modifying effect, not proof of one.

What to keep in mind

The reported findings are at 6 months, and the authors state that longer-term confirmation is needed. The pain-response comparison uses a modified intention-to-treat worst-case analysis and includes only participants who underwent a temporary SCS trial in the SCS group.