Age Related Osteoporosis, Knee Joint Contracture, Osteo Arthritis Knee, Pain
Conditions
Keywords
Pain, Osteo Arthritis Knee, Knee, Ultrasound, Joint mobility
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
Interventions
DEVICELow 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
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Safety and Efficacy Following Use of Investigational Device | From device use through completion of the final study visit, up to one year | The number of participants who report any device-related safety concerns following use of the investigational non-significant risk device, as assessed by participant-reported surveys. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with Osteoarthritic Joints Reaction to the LFU | one year | To determine the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, which will be denoted by surveys. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORThomas Blackwell
University of Texas Medical Branch, Galveston
Outcome results
None listed