A Novel Plantar Stimulation Technology for Improving Protective Sensation and Postural Control in Patients with Diabetic Peripheral Neuropathy: A Double-Blinded, Randomized Study

Abstract

Background: Many diabetes-related peripheral neuropathy (DPN) patients also experience postural instability. Objective: This study examined the effect of electrical stimulation therapy on DPN patients' postural control as well as recovery of plantar sensation. Methods: 54 patients with mild to moderate DPN were enrolled into this study evaluating treatment of DPN with electrical stimulation provided via aqueous solution. The subjects were randomized into either sham or active stimulation. Treatments were administered 5 times per week for 6 weeks. Changes in neuropathy severity were assessed via Semmes-Weinstein monofilament tests and vibration perception threshold (VPT) tests. The potential benefit in postural control was assessed in a subsample of 13 subjects by measuring the area of center of mass (COM) sway. Results: The active group saw a significant (p < 0.05) improvement in VPT at treatment week 6 in comparison to the sham group. The difference did not remain significant at follow-up visits. There were no significant differences between groups for the Semmes-Weinstein monofilament test. However, time was a significant main effect, with both groups improving over the course of the study. The area of COM sway was significantly reduced on average by 36% at treatment week 2 compared to the baseline. Although at treatment week 6 an additional 7% reduction in COM sway was observed compared to treatment week 2, the improvement from treatment week 2 to treatment week 6 was not significant (p > 0.6). Interestingly, no significant difference was observed in the sham group during the study (p > 0.7). Conclusion: This randomized pilot study provides preliminary data on the potential of electrical stimulation via aqueous solution to improve protective sensation and postural stability in DPN patients.