Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study.

People with diabetic peripheral neuropathy (DPN) experience a lower quality of life caused by associated pain, loss of sensation and mobility impairment. Current standard care for DPN is limited and lacking. This study explores the benefits of 4-week, in-home wearable focal muscle vibration (FMV) therapy on pain, balance, mobility, and sensation in people with DPN. Participants were randomized into three groups and received different FMV intensities. FMV was applied using a modified MyovoltTM wearable device to the tibialis anterior, distal quadriceps, and gastrocnemius/soleus muscles on both lower limbs for three days a week over four weeks. The outcomes included pain, balance, mobility, sensation, device usage log, feedback survey, and a semi-structured interview. In all, 23 participants completed the study. The results showed significant improvement in average pain (Pre: 4.00 ± 2.29; Post: 3.18 ± 2.26; p = 0.007), pain interference with walking ability (Pre: 4.14 ± 3.20; Post: 3.09 ± 1.976; p = 0.03), and standard and cognitive Timed Up-and-Go scores (Pre: 13.75 ± 5.34; Post: 12.65 ± 5.25; p = 0.04; Pre: 15.12 ± 6.60; Post: 12.71 ± 5.57; p = 0.003, respectively); the overall pain improvement was trending towards significance (Pre: 3.48 ± 2.56; Post: 2.87 ± 1.85; p = 0.051). Balance and sensations improved but not significantly. There was a trend towards significance (p = 0.088), correlation (r = 0.382) between changes in balance and baseline pain. The participants were highly satisfied with wearable FMV and were 100% compliant. FMV therapy was associated with improved pain, mobility, and sensation. Further study with a larger sample and better outcome measures are warranted.

RCT Entities:   Population Interventions Outcomes