Using low frequency ultrasound to help heal knee osteoarthritis

Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

This study is testing a new ultrasound device to see if it can help people with knee osteoarthritis feel better and move more easily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: The University of Texas Medical Branch, Galveston (Academic / other)
• Locations: 1 site (Galveston, Texas)
• Trial ID: NCT06562374 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the safety and effectiveness of a new experimental ultrasound bath device that utilizes low frequency ultrasound (LFU) to treat osteoarthritis of the knee. The device operates at a frequency of 33 kHz and delivers ultrasound in cycles to promote healing in patients with chronic knee pain. Participants will report their outcomes to assess how well the treatment works and its impact on their joint mobility. The intervention will be administered every second or third day to allow for optimal healing.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40 and older who have experienced chronic knee pain for at least six months.

Not a fit: Patients with other types of arthritis or those who have had recent surgeries or treatments on the affected knee may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for pain relief and improved joint function in patients with knee osteoarthritis.

How similar studies have performed: While this approach is novel, similar studies using ultrasound for pain management have shown promising results, indicating potential for success.

Eligibility 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 \</= 350 lbs.

Where this trial is running

Galveston, Texas

• University of Texas Medical Branch, Galveston — Galveston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Blackwell — University of Texas Medical Branch, Galveston
• Study coordinator: Thomas Blackwell

Conditions Osteo Arthritis Knee; Age Related Osteoporosis; Pain; Knee Joint Contracture; Knee; Ultrasound; Joint mobility