The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00822198 |
|
Recruitment Status :
Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral Neuropathy | Device: plantar vibration | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Plantar Vibration on the Progression of Peripheral Neuropathy |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | August 2007 |
| Arm | Intervention/treatment |
|---|---|
|
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. |
- intraepidermal nerve fiber density in ankle and thigh [ Time Frame: 0, 6 and 12 months ]
- quality of life score [ Time Frame: 0, 6 and 12 months ]
- clinical assessment of peripheral neuropathy [ Time Frame: 0, 6 and 12 months ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822198
| United States, New York | |
| Neurology Associates | |
| Corning, New York, United States, 14830 | |
| Principal Investigator: | Leann M Lesperance, MD, PhD | Binghamton University |
| Responsible Party: | Leann Lesperance, Binghamton University |
| ClinicalTrials.gov Identifier: | NCT00822198 History of Changes |
| Other Study ID Numbers: |
240-05 |
| First Posted: | January 14, 2009 Key Record Dates |
| Last Update Posted: | January 14, 2009 |
| Last Verified: | January 2009 |
Keywords provided by Binghamton University:
|
peripheral neuropathy diabetes plantar vibration |
Additional relevant MeSH terms:
|
Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |