Clinical trial NCT00822198: The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy
Official title: The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: peripheral neuropathy
diabetes
plantar vibration
Lead sponsor: Binghamton University
Sponsor class: OTHER
Collaborators: name: NY State Office of Science, Technology and Academic Research (NYSTAR)
First posted: 2009-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: intraepidermal nerve fiber density in ankle and thigh
timeFrame: 0, 6 and 12 months
Secondary outcomes:
measure: quality of life score
timeFrame: 0, 6 and 12 months
measure: clinical assessment of peripheral neuropathy
timeFrame: 0, 6 and 12 months
Other outcomes:
Locations:
city: Corning
country: United States
facility: Neurology Associates
state: New York
Study officials:
affiliation: Binghamton University
name: Leann M Lesperance, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: