IntroductionDistal symmetrical polyneuropathy is the most common type of diabetic neuropathy. Acupuncture has been used to treat distal symmetrical polyneuropathy; however, previous clinical trials of acupuncture in treating this disorder were limited by methodological defects; therefore, high-quality research is required. This trial aims to assess the efficacy and safety of acupuncture in the treatment of diabetic distal symmetrical polyneuropathy. MethodsThis study is a patient- assessor- blinded, double center, randomized controlled trial. A total of 210 patients with DSPN will be randomly assigned the study group or the control group in a ratio of 1:1. The study group (n = 105) will receive acupuncture, the control group (n = 105) will receive sham acupuncture. In addition, standard anti-hyperglycemic care will be provided to all patients. After baseline assessment, all treatments will be administered 3 times per week for 6 weeks, with a follow-up period of 8 weeks. The primary outcome is the Neuropathy Disability Score. Secondary outcomes are the Nerve Conduction Velocity; the Total Symptom Score; the Beck Depression Inventory II; and the Short-Form Health Survey 36. All outcome measures will be assessed at the baseline, 3 weeks, 6 weeks and 14 weeks. Adverse events will be recorded during this study to assess the safety of treatment. DiscussionThis study will assess the effect of acupuncture on distal symmetrical polyneuropathy and aims to provide clinical evidence for the efficacy of acupuncture in treating this disorder.
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