The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

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

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: plantar vibration

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Corning, New York, United States, 14830
      • Neurology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: plantar vibration; Subject will use Juvent plantar vibration device daily in the home or office for six months.

Device: plantar vibration; Subjects in the experimental component of the trial will be provided with a Juvent 1000-CS device in their home or workplace. The device will be placed in a convenient location where the device does not represent a trip hazard, and yet is readily accessible for use. The subjects will be instructed to use the device whenever it is convenient to do so, either by standing on the device, or by sitting with their feet on the device. Downloads of usage data will be obtained intermittently. Period interviews with the subjects will be conducted to ensure that the device is operating and that no problems are encountered with device usage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intraepidermal nerve fiber density in ankle and thigh	0, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life score	0, 6 and 12 months
clinical assessment of peripheral neuropathy	0, 6 and 12 months

Collaborators and Investigators

• Sponsor: Binghamton University
• Collaborators: NY State Office of Science, Technology and Academic Research (NYSTAR)
• Investigators: Principal Investigator: Leann M Lesperance, MD, PhD, Binghamton University

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): August 1, 2007
• Study Completion (ACTUAL): August 1, 2007

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (ESTIMATE): January 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2009
• Last Update Submitted That Met QC Criteria: January 13, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: diabetes; peripheral neuropathy; plantar vibration
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 240-05