Clinical trial NCT06562374: Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
Official title: Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Age Related Osteoporosis
Pain
Knee Joint Contracture
Keywords: Pain
Osteo Arthritis Knee
Knee
Ultrasound
Joint mobility
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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.

Primary outcomes:
measure: Safety and Efficacy for non significant risk device
timeFrame: one year
Secondary outcomes:
measure: Participants with Osteoarthritic Joints Reaction to the LFU
timeFrame: one year
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Galveston
state: Texas
Study officials:
affiliation: University of Texas Medical Branch, Galveston
name: Thomas Blackwell
role: PRINCIPAL_INVESTIGATOR
References: