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NCT Number: NCT06058169

Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)

The purpose of this proposal is to understand how the Vibrant Health Ultimate whole-body vibration (WBV) machine affects pain and inflammation in older adults. The investigators' hypothesize that sub-acute (12 weeks) WBV will lead to improvement in the level of knee pain and improve vascular function via a decrease in systemic inflammation.

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Key information

Conditions

Whole Body Vibration Osteo Arthritis Knee

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology

Augusta, Georgia, 30912, United States

Location status: Recruiting

Location contact

Reva Crandall, BS

CONTACT

[email protected]

706-721-5483

Ryan Harris, PhD, CEP

CONTACT

[email protected]

706-721-5998

About this study

Knee osteoarthritis (KO) is a leading cause of disability and medical cost. Whole body vibration (WBV) has emerged as an exercise alternative that may be more tolerable than traditional forms of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise, research supports that WBV can be very beneficial for your health. In fact, a single bout of WBV increases circulating concentrations of inflammatory markers. WBV is safe and effective, WBV training has been conducted in obesity, elderly, patients with diabetes, patients with lung disease, as well as patients with knee osteoarthritis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic Osteoarthritic knee pain for at least 6 months.
  • Mean and women
  • Ages 40-75 years old

Exclusion criteria

  • <40 years old or >75 years old
  • History of balance issues
  • History of falls
  • Epilepsy
  • Pregnancy
  • The use of whole-body vibration in the past 6 months
  • Previous knee surgery within last 3 years
  • Unable to stand for at least 20 minutes (for whole body vibration training)

Treatment and study plan

Sub Acute Whole Body Vibration Training

Device

Participants will be given a personal vibration plate (equipped with stabilizing bars) to take home for training which will last for up 12 weeks. For this test the participant will be asked to stand on a vibration plate for up to 20 minutes. Participants will be instructed to remove any footwear and stand mid-center on the platform in a standing position with feet shoulder width apart. The participant will be asked to step on and off of the vibration plate. During the first four weeks, participants will be asked to complete 5-10 minutes of WBV per day, at least 4-5 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 15 minutes and/or reduce the duration of rest. Beginning at week 9, based on how the participant feels, the study team may adjust the WBV time/duration up to 20 minutes per session, 4-5 days per week.

Primary outcomes

  1. Change in Pain Pressure Threshold assessed using the Jtech Medical Echo Algometer

    Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration

    change from baseline pain pressure threshold at 12 weeks. Pain Pressure Threshold (PPT) will be assessed using the Jtech Medical Echo Algometer. PPT is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing non-painful pressure stimulus turns into an uncomfortable or painful pressure sensation. The subject will lie supine. An investigator will assess PPT at the following sites: a) 2 cm below the medial edge of the patella and b) 2 cm below the lateral edge of the patella. Using the 1 cm2 probe, the investigator will place it perpendicular to each site and apply pressure at a rate of 0.5 kg/cm2/s. Each trial will stop when the subject reports pain. The investigator will take 3 trials at each site; the average of the 3 trials, recorded in kg/cm2, will be used for statistical analysis.

Secondary outcomes

  1. Change in Pulse Wave Velocity (PWV)

    Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration

    Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.

  2. Change in IL-6

    Time frame: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration

    change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Looney, MS

CONTACT

[email protected]

7067215483

Ryan Harris, PhD

CONTACT

[email protected]

7067215998

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Pilot Investigation on the Effects of Sub Acute (12 Week) Home Base Whole-body Vibration Training in Osteoarthritis.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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