The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.
Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Myovolt delivers vibration with a frequency between 60-300 Hz, and acceleration force between 1.8g to 19.1g peak to peak. Myovolt intensity will be set to \~up to 2X the participant's initial Myovolt perception threshold (however, the maximum intensity will be limited to 19.1g which is the maximum intensity the device can deliver). If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Changes in CMAP
The peroneal compound muscle action potential (CMAP)
Time frame: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks
Changes in NCV
The peroneal motor nerve conduction velocity
Time frame: Change from Baseline NCV measures every 2 weeks for up to 6 weeks
Changes in SNAP
The digital sensory nerve action potentials
Time frame: Change from Baseline SNAP measures every 2 weeks for up to 6 weeks
Changes in BPI-DPN
The Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy
Time frame: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks
Changes in TUG
Timed Up and Go (TUG) test
Time frame: Change from Baseline TUG scores every 2 weeks for up to 6 weeks
Changes in NTSS-6
The Neuropathy Total Symptom Score - 6-items (NTSS-6), which quantifies frequency and intensity of aching, burning, prickling and lancinating pain, numbness, and allodynia in patients' feet and legs.
Time frame: Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks
Changes in NSS
The Neuropathy Symptom Score (NSS), which quantifies symptoms of motor, sensory, and autonomic deficits.
Time frame: Change from Baseline NSS scores every 2 weeks for up to 6 weeks
Changes in NIS
The Neurologic Impairment Score (NIS), composed of a sensory sub-score (which evaluates sensory perceptions to touch, prickling pain, vibration, joint position, and 1- and 10-g monofilaments in the upper and lower extremities) and a motor sub-score (which evaluates cranial nerves, muscle strength, muscle wasting, and deep tendon reflexes in the upper and lower extremities).
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Time frame: Change from Baseline NIS scores every 2 weeks for up to 6 weeks