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Suspended by IRB
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Frequency Ultrasound (LFU) Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Frequency Ultrasound Therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-Reported Safety and Efficacy Following Use of Investigational Device | 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. | From device use through completion of the final study visit, up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with Osteoarthritic Joints Reaction to the LFU | 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. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Blackwell | University of Texas Medical Branch, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch, Galveston | Galveston | Texas | 777555 | United States |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |