Beyond pain relief: can 10-kHz spinal cord stimulation Improve sensory function in painful diabetic neuropathy?
Aims: To evaluate whether high-frequency 10-kHz spinal cord stimulation (SCS), alongside conventional medical management, improves pain and sensory function in people with painful diabetic neuropathy (PDN).
Methods: The PDN-Sensory study was a multicentre randomised controlled trial involving 91 participants allocated to conventional medical management alone (n=50) or 10-kHz SCS plus conventional management (n=41). Outcomes included pain reduction, sensory function assessed using the modified Toronto Clinical Neuropathy Score (mTCNS), intraepidermal nerve fibre density (IENFD), sleep and quality of life, assessed over six months.
Results: In a conservative modified intention-to-treat analysis, 27/34 participants undergoing a temporary SCS trial achieved at least 50% pain relief, compared with 2/50 receiving conventional management alone (p<0.001). At six months, clinically meaningful sensory improvement occurred in 55.2% of the SCS group versus 25.0% of controls (p=0.01). Mean IENFD increased by 0.58 fibres/mm with SCS, compared with a decrease of 0.07 fibres/mm in controls (p=0.03). Improvements were also observed in sleep and quality of life.
Conclusions: High-frequency SCS improved pain and sensory function in people with treatment-resistant PDN, with accompanying increases in small nerve fibre density.
Comments. This multicentre randomised controlled trial provides clinically relevant evidence that SCS may improve both pain and objective measures of sensory function in people with refractory PDN. A key strength is the inclusion of blinded assessments of sensory function and skin biopsy outcomes, providing evidence beyond patient-reported pain scores. The IENFD findings are particularly interesting given the lack of established disease-modifying treatments for diabetic neuropathy. However, the sample size was relatively small, follow-up was limited to six months, and participants were aware of their treatment allocation, potentially influencing subjective outcomes. The study was stopped early for efficacy, which may exaggerate treatment effects. The population had treatment-resistant neuropathy and therefore encouraging that improvements were seen. Overall, this is a promising study that warrants longer follow-up in a larger cohort with independent replication to determine whether SCS can be considered a disease-modifying intervention.
Shazli Azmi
Reference. Hurley RW, Siraj ES, Sills S, Engle M, Johnson C, Pop-Busui R, Armstrong D, Boulton A, Levy B, Tesfaye S, Grunberger G, Petersen E, Azalde R, Edgar D, Nakhle S, Yu C, Khan K, Skaribas I, Amirdelfan K, Nguyen Q, Jameson J, Guirguis M, Bradley K, Patel JS, Bintrim DJ, Caraway D. 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 Nov 1;49(11):2022-2032. doi: 10.2337/dc26-0758. PMID: 42713876.
