Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis

Starting soon · Phase 2

Conditions studied: Arthritis, Osteo Arthritis of the Knee

In brief

The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.

Key facts

Study ID

NCT07515872

Run by

ZetrOZ, Inc.

People needed

240

Starts

2026-05-01

Expected to finish

2028-05-31

Last updated by the study team

2026-04-07

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Orthopaedic Foundation — Stamford, Connecticut, United States
• Cayuga Medical Center - Medical Pain Consultants — Dryden, New York, United States

Full record on ClinicalTrials.gov

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