Osteo Arthritis KneeNCT06562374
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
A study testing Low Frequency Ultrasound Therapy in people with Osteo Arthritis Knee and Age Related Osteoporosis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Age Related Osteoporosis, Pain
- What is being tested?
- Low Frequency Ultrasound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
- Adults at least ≥40 years of age at the time of consent.
- Chronic knee pain within the past 6 months.
Who cannot join
- Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
- Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- 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.
- Subject's vitals are unstable or not in range for a safe study visit.
- History of fecal incontinence.
- Vomiting/Diarrheal illness within the past 7 days or at any time during the study.
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- Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study.
- 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)
- 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.
- Females who are pregnant or lactating.
- Inability to comply with study protocol.
- Incarcerated individuals.
- Non-English speaking subjects.
- Participant's weight must be </= 350 lbs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch, Galveston
Galveston, Texas, 777555
About this study
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.
Read the 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
- Being tested
- Low Frequency Ultrasound Therapy
- Keywords
- Pain, Osteo Arthritis Knee, Knee, Ultrasound, Joint mobility
- Medical subject headings
- Osteoporosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Frequency Ultrasound TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low Frequency Ultrasound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From device use through completion of the final study visit, up to one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start31 Jul 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Suspended by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Blackwell, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562374
- Sponsor's protocol ID
- 23-0164
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation
- ClinicalTrials.gov ID
- NCT06562374
- Acronym / sponsor ID
- 23-0164
- Keywords
- Pain, Osteo Arthritis Knee, Knee, Ultrasound, Joint mobility
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended by IRB
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Frequency Ultrasound (LFU) Intervention | Experimental | Device: Low Frequency Ultrasound TherapySubjects 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
- Adults at least ≥40 years of age at the time of consent.
- Chronic knee pain within the past 6 months.
Key exclusion criteria (14 listed)
- Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
- Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- 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.
- Subject's vitals are unstable or not in range for a safe study visit.
- History of fecal incontinence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Frequency Ultrasound TherapyThe 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 | Device | Low Frequency Ultrasound (LFU) Intervention |
Primary outcome
Participant-Reported Safety and Efficacy Following Use of Investigational Device
Time frame: 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.
1 secondary outcome
Participants with Osteoarthritic Joints Reaction to the LFU
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Blackwell principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Frequency Ultrasound Therapy in people with Osteo Arthritis Knee and Age Related Osteoporosis, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-Reported Safety and Efficacy Following Use of Investigational Device (time frame: From device use through completion of the final study visit, up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.