The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

This study has been completed.
Sponsor:
Collaborator:
NY State Office of Science, Technology and Academic Research (NYSTAR)
Information provided by:
Binghamton University
ClinicalTrials.gov Identifier:
NCT00822198
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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


Condition Intervention
Peripheral Neuropathy
Device: plantar vibration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Binghamton University:

Primary Outcome Measures:
  • intraepidermal nerve fiber density in ankle and thigh [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life score [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
  • clinical assessment of peripheral neuropathy [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822198

Locations
United States, New York
Neurology Associates
Corning, New York, United States, 14830
Sponsors and Collaborators
Binghamton University
NY State Office of Science, Technology and Academic Research (NYSTAR)
Investigators
Principal Investigator: Leann M Lesperance, MD, PhD Binghamton University
  More Information

No publications provided

Responsible Party: Leann Lesperance, Binghamton University
ClinicalTrials.gov Identifier: NCT00822198     History of Changes
Other Study ID Numbers: 240-05
Study First Received: January 13, 2009
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Binghamton University:
peripheral neuropathy
diabetes
plantar vibration

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 23, 2014