Status:
RECRUITING
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Osteo Arthritis Knee
Age Related Osteoporosis
Eligibility:
All Genders
40+ years
Phase:
NA
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 hel...
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...
Eligibility Criteria
Inclusion
- Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
- Adults at least ≥40 years of age at the time of consent.
- Chronic knee pain within the past 6 months.
Exclusion
- Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
- Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- History of replacement surgery, acupuncture therapy on the joint/knee under study within the past 6 months, or systemic corticosteroids within the study period and previous 30 days.
- Subject's vitals are unstable or not in range for a safe study visit.
- History of fecal incontinence.
- Vomiting/Diarrheal illness within the past 7 days or at any time during the study.
- Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study.
- Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days (eg. vancomycin resistant enterococcus, methicillin-resistant Staphylococcus, Candida auris, extended- spectrum beta lactamase bacteria)
- History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
- Females who are pregnant or lactating.
- Inability to comply with study protocol.
- Incarcerated individuals.
- Non-English speaking subjects.
- Participant's weight must be \</= 350 lbs.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06562374
Start Date
July 31 2024
End Date
July 31 2025
Last Update
August 20 2024
Active Locations (1)
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1
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 777555