The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

Not Applicable

Completed

• Conditions: Peripheral Neuropathy
• Interventions: Device: plantar vibration

• Registration Number: NCT00822198
• Lead Sponsor: Binghamton University

Brief Summary

The purpose of this study is to assess the effect of vibration of the plantar surface of the foot on peripheral neuropathy.

Detailed Description

Background: Peripheral neuropathy has a prevalence approaching 10% in the general population. The pathophysiology of peripheral neuropathy is poorly understood or undetermined. While many causes of peripheral neuropathy are known, a significant number of cases are idiopathic. The most common cause of neuropathy relates to glucose intolerance or overt diabetes. Exogenous factors such as smoking constrict small cutaneous blood vessels, thereby inhibiting small nerve fiber nutrition. Symptoms of neuropathy include numbness, pain, difficulty with balance, lack of temperature perception, and weakness which can lead to significant disability. Classification of neuropathies can be made based on nerve fiber size: large fiber, small fiber and mixed large and small fiber types. Plantar vibration which affects large fibers has been demonstrated to enhance peripheral and systemic blood flow, peripheral lymphatic and venous drainage (Stewart, Karman, Montgomery, \& McLeod, 2005). Since fluid retention in axons, nerve sheaths and surrounding connective tissues may contribute to neuropathy, it is hypothesized that plantar vibration may repair the small peripheral fibers, thereby improving the symptoms of neuropathy.

Purposes:

1. To assess the effect of plantar vibration on regeneration of small peripheral nerve fibers, peripheral neuropathy and quality of life in patients with diagnosed peripheral neuropathy.

2. To assess the correlation of health history, demographic variables, diet, alcohol and smoking history with small fiber neuropathy analysis by skin biopsy and plantar vibration.

Design: The study will employ a cross-over experimental design with subjects acting as their own controls. Independent variables are the plantar stimulation (intervention), and the characteristics of the subjects that include health history, demographic variables, self reported diet, alcohol, and smoking history, as well as urinary cotinine (a quantitative measure of smoking history). The dependent variables are the assay of intraepidermal nerve fibers in small-fiber neuropathy, clinical assessment of peripheral neuropathy, serum levels of Hgb A1C, and quality of life measurement.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Clinical evidence of neuropathy
• Normal to moderate evidence of neuropathy on nerve conduction studies

Exclusion Criteria

• Currently on medications with a known risk of neuropathy
• Pregnant
• Evidence of peripheral vascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
plantar vibration	plantar vibration	Subject will use Juvent plantar vibration device daily in the home or office for six months.

Primary Outcome Measures

Name	Time	Method
intraepidermal nerve fiber density in ankle and thigh	0, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
quality of life score	0, 6 and 12 months
clinical assessment of peripheral neuropathy	0, 6 and 12 months

Trial Locations

Locations (1)

Neurology Associates; 🇺🇸 Corning, New York, United States