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

NCT06058169 | Recruiting

• 1 other identifier: 2054289
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Whole Body Vibration; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• Change in Pulse Wave Velocity (PWV)

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

• Change in IL-6

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

Study Arms (1)

Whole Body Training (12 week)

EXPERIMENTAL

Device: Sub Acute Whole Body Vibration Training

Interventions

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.

Whole Body Training (12 week)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

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

Augusta, Georgia, 30912, United States

RECRUITING

Central Study Contacts

Reva Crandall, BS

CONTACT

7067215483; rcrandall@augusta.edu

Ryan Harris, PhD

CONTACT

7067215998; ryharris@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: April 25, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)