Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorAugusta University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic Osteoarthritic knee pain for at least 6 months.
Mean and women
Ages 40-75 years old
Disqualifiers
<40 years old or >75 years old
History of balance issues
History of falls
Epilepsy
Trial design
Design model
Single group
Treatments tested in this trial
Sub Acute Whole Body Vibration Training
DeviceParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Whole Body Training (12 week)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibrationSecondary outcomes
1
Change in Pulse Wave Velocity (PWV)
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s.
Time frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration2
Change in IL-6
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.
Time frame
pre-treatment baseline and following 12 weeks sub-acute whole-body vibrationSponsors and contacts
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Source ClinicalTrials.gov