The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

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.
    

Intervention name(s): plantar vibration
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral neuropathy; diabetes; plantar vibration