Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562374
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 16 seconds on and 16 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None