Trial reportDiabetes care2026
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).
Trial report in Diabetes care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The trial behind it
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Who cites it
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Authors and funding
26 authors.
Funding
Abstract
objectiveThe PDN-Sensory randomized controlled trial (RCT) evaluated the effects of high-frequency 10-kHz spinal cord stimulation (10-kHz SCS) on pain and sensory function in individuals with painful diabetic neuropathy (PDN). RESEARCH DESIGN AND
methodsParticipants were randomized 1:1 to conventional medical management (CMM) alone or 10-kHz SCS plus CMM. The primary and key secondary end points were the proportions of participants with pain response (≥50% lower-limb pain relief) and sensory improvement (≥3-point reduction in modified Toronto Clinical Neuropathy Score [mTCNS]). Hierarchical secondary outcomes included intraepidermal nerve fiber density (IENFD), sleep, and health- and neuropathy-related quality of life (QoL). IENFD and mTCNS assessments were allocation blinded.
resultsA total of 91 participants were randomly assigned to CMM alone (n = 50) or 10-kHz SCS plus CMM (n = 41). In a modified intention-to-treat worst-case analysis, 27 of 34 participants in the 10-kHz SCS group who underwent a temporary trial achieved the primary outcome, versus 2 of 50 CMM-alone participants (P < 0.001). Among those with 6-month data, mTCNS sensory improvement was observed in 16 of 29 (55.2%) 10-kHz SCS participants versus 12 of 48 (25.0%) CMM-alone participants (P = 0.01). The mean change in lower-calf IENFD was 0.58 fibers/mm with 10-kHz SCS versus -0.07 with CMM alone (P = 0.03). Eight of 10 hierarchical secondary end points were met (including sleep and QoL).
conclusionsThe PDN-Sensory RCT replicated previous pain-reduction findings and showed prespecified, objective improvements in sensory function and IENFD. These 6-month findings support clinically meaningful benefit and are consistent with a potential disease-modifying effect that requires longer-term confirmation.
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Registered trials
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