The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Other: passive vibration; Other: no passive vibration

Detailed Description

The study involves the following:

• Visit 1:
• Particpant's age, height, gender, and weight will be collected.
• Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
• Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
• After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
• The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
• The control group will not receive any treatment and they will continue their usual lifestyle.
• Visit 2 through 8:
• The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
• The control group will continue their usual lifestyle.
• In the fifth session, the treatment and control groups will come back for tests.
• Visit 9 (follow-up):

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A diagnosis of Diabetic Peripheral Neuropathy
• Minimum age 40 years
• Maximum Age 75 years
• Ability to stand for a minimum of five minutes

Exclusion Criteria:

• Neurological Disorders
• Bleeding Disorders
• Leg Ulcers
• Cardiovascular Diseases
• Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
• Self-reported pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: passive vibration group; The passive vibration group patients will receive passive vibration (50 Hz, one cycle= 60 seconds working time with 2 seconds rest time) on their calf in supine position for ten minutes. The total number of sessions will be nine. Passive vibration will be given to the treatment group twice a week for four weeks (eight sessions) and the ninth session will be the follow up. At every session, the skin blood flow will be measured before, immediately, and 15 minutes after passive vibration.	Other: passive vibration; The passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time).
ACTIVE_COMPARATOR: no passive vibration group; The control group will not receive any treatment and continue their usual lifestyle. Balance, sensory measurement and skin blood flow will be taken at the beginning of the study, prior to the 5th treatment, and 1 week after the last intervention .	Other: no passive vibration; The control group will not receive any treatment and continue their usual lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin blood flow	Patient will be positioned in prone on a plinth as their skin is marked for blood flow assessment. A 3 cm x 3 cm square shape will be marked on the posterior aspect of the calf (muscle belly) and on the plantar aspect of the first three metatarsal heads. MOOR Full-field Laser Perfusion Image(FLPI) (MOOR FLPI V 2.1, Oxford, England) will be used for measurement of skin blood flow in a patient with DPN, which will be pre-warmed for about 30 minutes. The perpendicular red light laser beam will be used to capture SBF and blood flow is measured in '"Flux" unit.	Change between Baseline and Week Nine Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
balance	The NeuroCom Smart Balance Master System Computerized dynamic posturography (CDP) will be used in this research to measure balance. The platform consists of two force plates that can be modulated in the up-down and anterior-posterior direction. The sensory organization test (SOT) will be used to measure balance. The result of CDP determines any anomalies in visual, somatosensory and vestibular systems that control posture.	at each of the nine visits( 90 minutes each visit: twice per week)

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: 5170453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No