A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain
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.
• Diagnosed with diabetes, aged between 18 and 80 years old;
• Symmetrical pain in the distal lower extremities with or without dysesthesia;
• Duration of symptoms exceeding 6 months;
• Pain described as stabbing and/or electric shock-like and/or burning sensation;
• Abnormal Quantitative Sensory Testing (QST);
• Presence of hyperalgesia and allodynia;
• Absence of lower limb reflexes and muscle strength abnormalities;
• Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities.