The effects of whole body vibrations on type 2 diabetes adults with painful peripheral neuropathies: a randomised controlled trial

Abstract

BACKGROUND: Neuropathies can have a large detrimental effect in diabetic populations. Non pharmacological and pharmacological treatments to ease neuropathic symptoms are on the rise, however optimal interventions to improve pain and quality of life in these individuals have not yet been found as there is still a lack of convincing results and research. The aim of this trial is to deepen our knowledge on potential modalities to help these patients. It will attempt to determine the effect of whole body vibrations in comparison to sham whole body vibrations (WBV) on painful neuropathies in type 2 diabetes mellitus (T2DM) subjects. METHODS: This study is a multi centre, randomized, double-blinded (patients and assessors), controlled trial with a 1:1 ratio. Participants will be sedentary adults over 50 diagnosed with T2DM and associated painful peripheral neuropathy. They will be randomly allocated to one of two groups; the WBV intervention group and the sham WBV group. The intervention will last 6 weeks, there will be 3 sessions of 3x4mins of synchronous WBV or sham WBV per week. The primary outcome will be pain, which will be measured with the visual analogue scale (VAS) before and after every WBV/sham WBV session. Secondary outcomes will include quality of life, glycemic profile, plantar sensitivity, aerobic capacity, lower limb strength and balance. These will be measured with the NeuroQoL, a fasting blood glucose test and HbA1c test, nylon Semmes-weinstein monofilament test, O2peak test, sit to stand test as well as Berg balance scale respectively. These assessments will be made at baseline, 3 weeks and 6 weeks. A follow up assessment will take place 6 weeks after the end of

the intervention. Data analysis to compare in between group results will be made using a student- t test.

DISCUSSION: Synchronous WBV training is a feasible and cheap intervention that could potentially improve pain as well as QoL, glycemic profile, plantar sensitivity, aerobic capacity, lower limb strength and balance in T2DM patients with painful peripheral neuropathies