The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

Loma Linda University (LLU)

Status: Withdrawn

Conditions: Diabetic Neuropathies

Treatments: Other: no passive vibration; Other: passive vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT03415256

5170453

Details and patient eligibility

About

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).

Full 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):

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

passive vibration group

Experimental group

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.

Treatment:

Other: passive vibration

no passive vibration group

Active Comparator group

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 .

Treatment:

Other: no passive vibration