The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03415256
• Other study ID #: 5170453
• Status: Withdrawn
• Phase: N/A
• Start date: November 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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):

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

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).
• no passive vibration
The control group will not receive any treatment and continue their usual lifestyle.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)