An Open-Label Comparative Study of the Impact of Two Types of Electrical Stimulation (Direct Current Neuromuscular...

Objective:The objective of this study is to evaluate and compare the effectiveness of treatments with two different electrical stimulation (e-stim) devices-pulsed direct current (DC) (Neubie) and alternating current (AC) (transcutaneous electrical stimulation (TENS))-in the treatment of symptoms for patients with diabetic peripheral neuropathy (DPN). Design:Randomized controlled trial (RCT) with parallel groups. Methods: One hundred fifty participants were recruited from 13 Hands-On Diagnostics-affiliated sites across several US locations. Participants were randomly divided into two groups for comparison-Neubie and TENS. Participants received a 30-min foot stimulation protocol with either TENS unit electrodes or Neubie electrodes. Outcome measures included the Toronto Clinical Neuropathy Score (TCNS), two-point discrimination, visual analogue scale (VAS), vibration sense (VBS), nerve conduction velocity (NCV), and nerve amplitude. The effect of the two variables on all outcome measures was determined using an analysis of covariance (ANCOVA). Results: The Neubie group demonstrated statistically significant improvements in TCNS for both right and left sides (p < 0.001), two-point discrimination of the dominant foot (p = 0.001), VBS (p = 0.022) and VAS scores (p = 0.009), and some but not all nerves tested by NCV (p < 0.05). Conclusion: Overall, DPN treatment with the Neubie resulted in significant improvements in several major outcome measures, whereas TENS showed no significant difference in any outcome measure. These findings support the use of DC devices as a potentially superior therapeutic treatment for neuropathy over AC devices like the TENS unit. Trial Registration: ClinicalTrials.gov identifier: NCT05442021.