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The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03415256
Recruitment Status : Withdrawn (Lack of time currently.)
First Posted : January 30, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Everett Lohman, Loma Linda University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Other: passive vibration Other: no passive vibration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Skin blood flow [ Time Frame: Change between Baseline and Week Nine Visit ]
    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 :
  1. balance [ Time Frame: at each of the nine visits( 90 minutes each visit: twice per week) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03415256


Locations
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United States, California
Loma Linda University
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Everett Lohman, DSc Loma Linda University
More Information
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Responsible Party: Everett Lohman, Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03415256    
Other Study ID Numbers: 5170453
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases