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临床试验/NCT00822198
NCT00822198已完成不适用

The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy

Binghamton University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
intraepidermal nerve fiber density in ankle and thigh

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical evidence of neuropathy
  • Normal to moderate evidence of neuropathy on nerve conduction studies

排除标准

  • Currently on medications with a known risk of neuropathy
  • Evidence of peripheral vascular disease

结局指标

主要结局

intraepidermal nerve fiber density in ankle and thigh

时间窗: 0, 6 and 12 months

次要结局

  • quality of life score(0, 6 and 12 months)
  • clinical assessment of peripheral neuropathy(0, 6 and 12 months)

研究者

申办方类型
Other

研究点 (2)

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