A Novel Non-Pharmacological Treatment of Diabetic Neuropathy
The objective of the proposed work is to develop non-pharmacological interventions for diabetic peripheral neuropathy (DPN), to improve quality of life of individuals with diabetes, and reduce the prevalence of opiate prescription, sensation loss, falls, and deaths caused by DPN. To this end, the proposed study will investigate and determine the feasibility of the non-pharmacological intervention device. The feasibility study involves 16 participants, split evenly between pre-neuropathic diabetic and neuropathic diabetic participants. During the study, each group will receive the same 45-minute intervention on 5 days spread over no more than 10 days total. Feasibility will be determined by change in pain assessed before and after intervention.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: Pilot Feasibility Arm
Each participant will receive the same 45-minute intervention on 5 days spread over no more than 10 days total. At the end of each session, pain will be assessed on scales such as the Defense and Veterans Pain Rating Scale (DVPRS) to establish the safety and feasibility of the proposed intervention.
Device: Non-pharmacological Heat, Pressure, and Vibration
The innovation central to this approach is in the multifactorial combination of pressure, heat, and vibration stimuli to improve foot sensation. The heat stimuli will be provided with commercially available heating elements. The pressure stimuli will be provided via a small, low power stepper motor connected to a nylon strap. Lastly, the vibrotactile stimuli will be provided with commercially available vibrotactile motors. The non-pharmacological DPN device will be able to safely and consistently control temperature to 100-105°F within 1°F, control pressure to 50 mmHg within 5 mmHg at 0.25 Hz, and provide 5 distinguishable vibrational stimuli to 5 zones on the leg and foot.
Primary Outcome Measures
- Change from Baseline Pain Assessment [immediately after each session (up to 30 minutes)]
Defense and Veterans Pain Rating Scale (DVPRS)
diagnosis of type 2 diabetes for at least 5 years
lab histories that verify participant's control or lack of blood sugars dating back for a period of 1-5 years
other diseases or impairments that could affect results (vascular disease verified from medical history
ankle-brachial index (ABI) of 0.9 or less
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Auburn University
- Principal Investigator: Chad G Rose, PhD, Auburn University
Study Documents (Full-Text)None provided.