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Long Duration High Frequency Ultrasound for Knee Osteoarthritis

This study is looking at how well a device called the Sustained Acoustic Medicine (SAM) device, which uses high-frequency ultrasound, can help reduce knee pain from osteoarthritis. It's also testing if adding a 2.5% diclofenac patch (a pain-relieving medication) to the ultrasound treatment works better than ultrasound alone, or a single injection of triamcinolone acetonide (a steroid). You might be able to join if you are between 65 and 85 years old, have mild to moderate knee osteoarthritis, and experience frequent knee pain that affects your quality of life. The study will measure changes in your pain levels and how well you can use your knee over 12 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 240 participants and compare three different treatments for knee osteoarthritis.
What's involved
You would self-apply your assigned treatment daily for 1-4 hours over 12 weeks. You will also record pain scores daily and complete quality of life and function assessments at the beginning and end of the study.
Compensation
Not stated in the trial record.
Follow-up
Your pain and function will be measured through study completion, which is an average of 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07515872

Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis

Not Yet Recruiting
PHASE2Ages 65–85InterventionalTreatment
ZetrOZ, Inc.
~240 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Sustained Acoustic Device with 2.5% Diclofenac PatchSustained Acoustic Device with 0% Diclofenac PatchIntra articular injection

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Measured over Through study completion, average of 12 weeks
+1 more outcome measured

Conditions

Arthritis
Osteo Arthritis of the Knee

Explore related trials

Osteoarthritis

Where it's being run

2 sites across 2 states
Connecticut1
New York1

Who to contact

Ralph Ortiz, DO, MPH
[email protected]
607-844-9979
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
Are between 65-85 years of age
Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
Report that knee pain negatively affects quality of life
Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
Are deemed appropriate by their physician or by the study site physician to participate.
Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
Not use or initiate use of opioid and/or non-opioid analgesic medications.
Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion

Cannot successfully demonstrate the ability to put on and take off the device.
Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
Is pregnant.
Is a prisoner.
Is non-ambulatory (unable to walk).
Has a pacemaker.
Has a malignancy in the treatment area.
Has an active infection, open sores, or wounds in the treatment area.
Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
Has a known neuropathy (disease of the brain or spinal nerves).
Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.
Are currently taking steroids.
Have any contraindication to radiograph.
Have a secondary cause of arthritis (metabolic or inflammatory).
Have a known contraindication, allergy, or hypersensitivity to corticosteroids or any component of Kenalog®-40 (if assigned to the injection group).

What this trial measures

  • Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From BaselineThrough study completion, average of 12 weeks

    Change in the self-described pain units on a scale by patient at baseline and post-treatment

  • Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Through study completion, average of 12 weeks.

    WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).