Painful Diabetic Peripheral Neuropathy

This study will evaluate the efficacy and safety of low-dose duloxetine combined with alpha-lipoic acid compared with standard-dose duloxetine in adults with painful diabetic peripheral neuropathy. In this assessor-blinded, randomized, parallel-arm, non-inferiority trial, participants will be assigned in a 1:1 ratio to receive either duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily or duloxetine 60 mg once daily. The primary outcome will be the change in pain intensity measured by the Numerical Rating Scale from baseline to Week 9. Secondary outcomes will include changes in pain intensity at Week 5, Patient Global Impression of Change at Weeks 5 and 9, the proportion of participants achieving at least a 30% reduction in pain intensity, adverse effects, treatment tolerability and treatment compliance.

Background: Painful diabetic peripheral neuropathy (PDPN) is a severe, disabling complication of type 2 diabetes mellitus (T2DM), closely associated with insulin resistance, chronic neuroinflammation, and oxidative stress. Plant-based dietary supplements, particularly Ceylon cinnamon (Cinnamomum verum), contain bioactive compounds with potential anti-diabetic, antioxidant, and neuroprotective properties. Aim: To evaluate the effects of Ceylon Cinnamon (Cinnamomum verum) supplementation on blood glucose, lipid profile levels, body mass index (BMI), and pain intensity among adult individuals with painful diabetic peripheral neuropathy (PDPN). Methods: A prospective, double-blind, randomized controlled trial (Double-Blind RCT) was conducted (Feb-July 2026) across endocrinology outpatient clinics in Jordan. Participants were randomly allocated in a 1:1 ratio to either the Intervention Group (n = 62; 500 mg Ceylon cinnamon twice daily for 6 months alongside standard care) or the Placebo Control Group (n = 62; 500 mg placebo capsules twice daily for 6 months alongside standard care). Clinical, biochemical, and pain assessments (using the Numeric Rating Scale \[NRS\]) were evaluated at baseline, 3 months, and 6 months post-intervention.

Application of High-Frequency Spinal Cord Stimulation (HF-SCS) in the Treatment of Painful Diabetic Peripheral Neuropathy (PDPN): A multicenter, randomized controlled study comparing its clinical efficacy with traditional spinal cord stimulation for PDPN. The study aims to observe the impact of HF-SCS on the neurological function and microcirculation of PDPN patients, elucidating the correlation between the underlying diabetes and the efficacy of HF-SCS therapy on PDPN. The goal is to enhance the treatment standards for PDPN, improve the quality of life for this population, and overall treatment outcomes. Simultaneously, the study aims to contribute evidence-based medicine for the mechanistic exploration of PDPN.