The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy

Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.

Inclusion Criteria:age between 20 and 80 yearshaving diabetes based on the criteria of the World Health Organization (WHO 1999)Having diabetic painful neuropathy for more than 1 month but less than 5 yearsno alcohol addiction (consumption<140g/week in men and <70g/week in women)no history of cerebral infarction/hemorrhage or other known nervous system diseaseno active infections in the skinExclusion Criteria:having abnormalities in levels of Vitamin B12, Hemoglobin, and TSH.HbA1C>10%having moderate or severe hepatic and renal dysfunctions.