Effect of electroacupuncture for pain relief in diabetic distal symmetric polyneuropathy: a pilot randomized clinical trial

Abstract

Background: Painful distal symmetric polyneuropathy (DSPN) is one of the most common complications of type 2 diabetes mellitus (T2DM), affecting quality of life and increasing the disease burden. Standard pharmacological treatments often provide suboptimal relief and may cause adverse effects, highlighting the need for alternative therapies. Electroacupuncture (EA), a traditional Chinese medicine technique, has shown promising clinical outcomes in pain reduction, but its role in diabetic neuropathy remains underexplored. This pilot clinical trial aimed to assess the efficacy of EA in reducing neuropathic pain in patients with T2DM and axonal DSPN. Methods: We conducted a pilot randomized, double-blind, sham-controlled trial in northern Mexico City (December 2021—August 2023). Eighteen patients with clinically and electrophysiologically confirmed axonal DSPN were randomly assigned to receive either true EA or sham EA, twice weekly for eight weeks (16 sessions, 20 min each). Neuropathic pain was evaluated using the Douleur Neuropathique en 4 Questions (DN-4) and Numeric Rating Scale (NRS) at baseline and post-intervention. Findings: After 16 sessions, the median DN-4 score change was not significant in either group. In contrast, the NRS scores showed reductions in the EA group: -2.78 points for current pain intensity (-58% from baseline, p = 0.028), -2.11 for least pain (-40%, p = 0.028), -4 for worst pain (-19%, p = 0.050), and -3.67 for average pain (-63%, p < 0.001). No significant changes were observed in the sham EA group. No adverse effects were reported. Conclusion: This pilot randomized clinical trial suggests that EA may reduce pain intensity compared to sham EA in patients with painful DSPN. However, these findings should be regarded as hypothesis-generating given the limited sample size. Larger, multicentre trials are needed to confirm these results and explore underlying mechanisms. Trial registration: CNIC-IMSS (R-2020–785-070; registered prospectively on May 26th, 2020), CONBIOÉTICA (09CEI00920160601), COFEPRIS (CI: 17 CI 09 015 006), ClinicalTrials.gov (NCT05521737; retrospectively registered on August 30th, 2022; first participant enrolled December 2021), and the International Clinical Trials Registry platform (ISRCTN97391213, retrospectively registered on September 12th, 2022).