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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06058169
• Other study ID #: 2054289
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: Augusta University
• Contact: Reva Crandall, BS
• Phone: 7067215483
• Email: rcrandall[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Whole Body Vibration

Intervention

Device:
• Sub Acute Whole Body Vibration Training
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.

Locations

Country	Name	City	State
United States	Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Pulse Wave Velocity (PWV)	Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
Secondary	Change in IL-6	change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.	pre-treatment baseline and following 12 weeks sub-acute whole-body vibration