NCT06562374

Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Osteo Arthritis Knee
• Age Related Osteoporosis
• Pain
• Knee Joint Contracture

Interventions

Type	Name	Description
DEVICE	Low Frequency Ultrasound Therapy	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

Timeline

• Start date: 2024-07-31
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-08-20
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States