Acupuncture versus sham acupuncture in the treatment of diabetic distal symmetric polyneuropathy (DSPN): Study protocol for a randomized controlled trial

Introduction: Distal 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. Methods: This 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. Discussion: This 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.