The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.
This initial study is a pilot study which is going to test the safety and efficacy of the developed ultrasound intervention for osteoarthritis, initially on osteoarthritis of the knee. This study is a pilot study to evaluate two distinct variables. The first is the safety and efficacy of the device, and the second is the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, using patient-reported outcomes associated with this study. The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing
University of Texas Medical Branch, Galveston
Galveston, Texas, United States
Participant-Reported Safety and Efficacy Following Use of Investigational Device
The number of participants who report any device-related safety concerns following use of the investigational non-significant risk device, as assessed by participant-reported surveys.
Time frame: From device use through completion of the final study visit, up to one year
Participants with Osteoarthritic Joints Reaction to the LFU
To determine the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, which will be denoted by surveys.
Time frame: one year
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