The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

NCT03415256 | Withdrawn

• 1 other identifier: 5170453
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• balance

  at each of the nine visits( 90 minutes each visit: twice per week)

Study Arms (2)

passive vibration group

EXPERIMENTAL

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

no passive vibration group

ACTIVE COMPARATOR

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

Interventions

passive vibration OTHER

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).

passive vibration group

no passive vibration OTHER

The control group will not receive any treatment and continue their usual lifestyle.

no passive vibration group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Everett Lohman, DSc

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * After completing the tests, you 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.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 30, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 28, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)