Abstract
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.
Highlights
Unless an effective intervention is found for diabetic peripheral neuropathy (DPN), one third of the 9.7 billion people in the world with diabetes will suffer its effects by 2050 [1].DPN affects approximately 50–70% of patients with diabetes and is the most common debilitating secondary complication [2,3]
BPI–DPN is Brief Pain Inventory-Diabetic Peripheral Neuropathy; BBS is Berg Balance Scale; Timed-Up and Go (TUG) is standard Timed Up-and-Go; TUG cognitive is the cognitive Timed Up-and-Go; SWMT is Semmes–Weinstein Monofilament Test; N is number of participants analyzed; BPI–DPN scores are measured out of 110 and the scores are scaled to a score between 0–10; All values are represented as mean (SD)
The significant improvement in the TUG scores and TUG cognitive scores indicates an improvement in functional mobility, which is further supported by the significant improvement in the “pain interference with walking ability” subscale of the BPI–DPN
Summary
Unless an effective intervention is found for diabetic peripheral neuropathy (DPN), one third of the 9.7 billion people in the world with diabetes will suffer its effects by 2050 [1]. The combined effects of these symptoms cause impairment in postural stability, balance, and functional mobility. This affects each patient’s ability to ambulate safely and independently and lowers their quality of life (QOL). WBV is a form of mechanical stimulation shown to reduce acute pain, improve balance and dynamic stability, improve glycemic control, and increase muscle strength in individuals with DPN [13,14]. Researchers studying vibration as a rehabilitation intervention shown evidence that focal vibration benefits spasticity, motor learning deficits, pain, balance and mobility impairment in patients with stroke, spinal cord injury, and multiple sclerosis [17]. The primary aim of this exploratory study was to explore the benefits over 4 weeks of wearable FMV therapy on pain, balance, mobility, and sensation in individuals with DPN.
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