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The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Neuropathies

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
passive vibration
no passive vibration
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Neuropathies

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

passive vibration group

no passive vibration group

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 12, 2017
Last Updated
February 26, 2019
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03415256
Brief Title
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Official Title
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of time currently.
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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):

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
passive vibration group
Arm Type
Experimental
Arm Description
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.
Arm Title
no passive vibration group
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
passive vibration
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
no passive vibration
Intervention Description
The control group will not receive any treatment and continue their usual lifestyle.
Primary Outcome Measure Information:
Title
Skin blood flow
Description
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.
Time Frame
Change between Baseline and Week Nine Visit
Secondary Outcome Measure Information:
Title
balance
Description
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.
Time Frame
at each of the nine visits( 90 minutes each visit: twice per week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Lohman, DSc
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

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