IS PHOTOBIOMODULATION AN EFFECTIVE NON-PHARMACOLOGICAL COMPLEMENT TO THE TREATMENT OF DIABETIC NEUROPATHY - A RANDOMIZED, PLACEBO-CONTROLLED TRIAL

Diabetes is one of the leading causes of health losses among the Bulgarian population. Diabetic neuropathy (DN) occurs in at least 34 % of people with type 1 diabetes after 25 years of disease duration and 20 % - 30 % of newly diagnosed patients with type 2 diabetes, increasing to 50 % after 10 years of disease duration. The treatment of DN is challenging. There is growing interest in non-pharmacological forms of treatment. High-power lasers have increasingly been used in the practice of physical and rehabilitation medicine. However, clinical trials testing their effectiveness in DN are scarce. Purpose: The aim of this single blinded, placebo-controlled field trial is to investigate the effect of a multiwave locked system (MLS laser) on sensory perception and electroneurographic parameters of sensory and motor nerves in patients with diabetic sensorimotor neuropathy of lower limbs. Material/Methods: A total of 69 patients were randomly assigned laser treatment (n=41) or placebo treatment (n-28) for three weeks, totaling 9 procedural sessions. Vibration sense was measured three times per session. Neurophysiological evaluations were conducted at baseline and on day 90. Results: On day 21, vibration sense increased bilaterally at all sites in the laser group, with statistically significant differences (p < 0.05 for all sites) compared to the placebo group, persisting through day 90. Nerve conduction velocity and amplitude of the sural, peroneal, and tibial nerves improved by day 90 from baseline, with superior results in the sural nerve. Conclusions: Deep tissue laser therapy can be considered a safe, non-pharmacological adjunct to the standard for managing diabetic neuropathy.