Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures. 2. Adults at least ≥40 years of age at the time of consent. 3. Chronic knee pain within the past 6 months.

Exclusion Criteria:

1. Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder. 2. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation. 3. 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. 4. Subject's vitals are unstable or not in range for a safe study visit. 5. History of fecal incontinence. 6. Vomiting/Diarrheal illness within the past 7 days or at any time during the study. 7. Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study. 8. 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) 9. 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. 10. Females who are pregnant or lactating. 11. Inability to comply with study protocol. 12. Incarcerated individuals. 13. Non-English speaking subjects. 14. Participant's weight must be

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06562374
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Texas Medical Branch, Galveston
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thomas Blackwell
Principal Investigator Affiliation	University of Texas Medical Branch, Galveston
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Knee, Age Related Osteoporosis, Pain, Knee Joint Contracture

Additional Details

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

Arms & Interventions

Arms

Experimental: Low Frequency Ultrasound (LFU) Intervention

Subjects will be given ultrasound at a frequency of 33 kHz with a program of 1.6 seconds on and 1.6 seconds off for 30 min at either a power level of 4 or 10 Pascals to determine which power level is optimal for osteoarthritis. Follow up visits after two-three days will be used to continue therapy.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Galveston, Texas

Status

Recruiting

Address

University of Texas Medical Branch, Galveston

Galveston, Texas, 777555

Site Contact

Lamonne Crutcher

[email protected]

409-772-1619

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