Effectiveness of 10.6-μm laser therapy for diabetic peripheral neuropathy: A double-blind, randomized controlled trial

OBJECTIVE: To observe the clinical effects of 10.6-μm laser moxibustion (LM) on diabetic peripheral neuropathy (DPN) and quality of life in patients. METHODS: Sixty-eight patients with DPN were randomly assigned to two groups in a 1:1 ratio and received LM or sham LM 3 times/week for a total of 12 treatments. Outcome parameters were assessed at baseline, at Weeks 2 and 4 of treatment, and at 4 and 8 weeks post-treatment (Weeks 8 and 12) using Michigan Neuropathy Screening Instrument (MNSI) and Diabetes-Specific Quality of Life (DSQL) scores, nerve conduction velocity (NCV), and blood rheology parameters. RESULTS: Most (58/68) patients completed the trial. MNSI scores were significantly lower at every time point (P < 0.01), and DSQL scores were significantly lower at Weeks 4, 8, and 12 (P < 0.001), compared with baseline in both groups. The LM group had lower MNSI scores at Week 4 (P < 0.05), and lower DSQL scores at Weeks 4, 8, and 12 (P < 0.05) compared with the sham LM group. At Week 4, there was no significant between-group difference in NCV (P > 0.05). Post-treatment, there were no significant differences in blood rheology parameters compared with baseline within each group (P > 0.05). Whole blood high-shear reductive viscosity and red blood cell rigidity index were significantly lower in the LM group than in the sham LM group (P < 0.01). No serious adverse events were recorded. CONCLUSION: Treatment with 10.6-μm LM improved clinical symptoms and quality of life in patients with DPN. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2000029329. Registered 25 January 2020, https://www.chictr.org.cn/showproj.html?proj=48490.