NCT05041816

Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Focal vibration therapy	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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-09-13
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study