Background: Diabetes mellitus affects more than half a billion people globally, often leading to painful diabetic neuropathy (PDN). Spinal cord stimulation (SCS) has emerged as a promising treatment for PDN.
Objective: This meta-analysis evaluated the efficacy of SCS compared with the best medical therapy (BMT) for PDN.
Materials and methods: Following the Preferred Reporting Items of Systematic reviews and Meta-Analyses guidelines, a systematic search of the PubMed, Scopus, Web of Science, Embase, and Cochrane CENTRAL data bases was conducted up to December 1, 2023 and updated on January 2, 2025. Data extraction was performed using Microsoft Excel, and quality assessment was conducted using Cochrane's Risk of Bias 2.0 and ROBINS-1 tools. Statistical analysis and heterogeneity assessment were performed using Review Manager (RevMan) software (The Cochrane Collaboration, London, UK).
Results: Nine clinical trials involving 407 patients were included. The analysis revealed significant pain reduction in the SCS group (mean difference [MD]: -5.46, 95% CI: [-6.09, -4.83], p < 0.00001). Subgroup analysis indicated pain relief benefits in both conventional SCS (MD: -4.176, 95% CI: [-4.865, -3.486], p < 0.001) and 10-kHz SCS (MD: -4.581, 95% CI: [-6.376, -2.785], p < 0.001). SCS also achieved higher treatment success rates (≥50% pain relief) than did BMT (risk difference: 0.59, 95% CI: [0.33, 0.85], p < 0.00001). Moreover, SCS significantly improved the EuroQol-5 Dimension utility index (MD: 0.16, 95% CI: [0.10, 0.23], p < 0.00001) and self-reported health (MD: 15.29, 95% CI: [4.51, 26.07], p = 0.005).
Conclusion: This meta-analysis provides robust evidence supporting SCS as an effective intervention for managing chronic pain and enhancing the quality of life in patients with PDN, highlighting its superiority to conventional medical therapy.
Keywords: Diabetes mellitus; SCS; neuromodulation; painful diabetic neuropathy; spinal cord stimulation.
Copyright © 2025 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.