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Completed

NCT Number: NCT00822198

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology Associates

Corning, New York, 14830, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plantar vibration

Device

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.

Primary outcomes

  1. intraepidermal nerve fiber density in ankle and thigh

    Time frame: 0, 6 and 12 months

Secondary outcomes

  1. quality of life score

    Time frame: 0, 6 and 12 months

  2. clinical assessment of peripheral neuropathy

    Time frame: 0, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Collaborators

  • NY State Office of Science, Technology and Academic Research (NYSTAR)

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 14, 2009
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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