SuspendedNot Applicable

Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

Stopped: Suspended by IRB

United States10 participantsStarted 2024-07-31

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

Participant-Reported Safety and Efficacy Following Use of Investigational Device

Timeframe: From device use through completion of the final study visit, up to one year

Trial details

NCT IDNCT06562374

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Osteo Arthritis Knee trials