{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T19:39:31Z","timestamp":1792525171322,"version":"4.5.0"},"reference-count":40,"publisher":"American Diabetes Association","issue":"11","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"funder":[{"name":"Nevro Corp"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>The 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>Participants 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 (\u226550% lower-limb pain relief) and sensory improvement (\u22653-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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>A 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 &amp;lt; 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 \u22120.07 with CMM alone (P = 0.03). Eight of 10 hierarchical secondary end points were met (including sleep and QoL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc26-0758","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T11:01:11Z","timestamp":1788951671000},"page":"2022-2032","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":0,"title":["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)"],"prefix":"10.2337","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6591-9390","authenticated-orcid":false,"given":"Robert W.","family":"Hurley","sequence":"first","affiliation":[{"name":"Pain Medicine, Anesthesiology, Translational Neuroscience and Public Health, 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