Not yet taking people in United StatesPhase 2

Long-lasting ultrasound treatment for knee pain from osteoarthritis

Tests long-duration ultrasound for knee pain caused by osteoarthritis.

Key facts

Who runs it: ZetrOZ, Inc.
Where: Dryden and Stamford, United StatesSee the 2 sites
Trial code: NCT07515872
Registry title: Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis
Status: Not yet recruiting
Phase: Phase 2
People taking part: 240 people, planned
Started: 1 May 2026
Expected to end: 31 May 2028
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Sustained Acoustic Device with 2.5% Diclofenac Patch
Sustained Acoustic Device with 0% Diclofenac Patch
Intra articular injection
Record updated: 7 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 65 to 85 with mild to moderate knee osteoarthritis pain. They must be willing to use an ultrasound device at home every day.

Age: 65 to 85 years
Sex: All sexes
Disease stage: Mild to moderate knee osteoarthritis (OARSI atlas grades 1-2), diagnosed by a doctor. It must meet the American College of Rheumatology clinical and X-ray criteria. Frequent pain score of 4-7 (on a 0-10 scale) in the week before joining. Knee pain must harm quality of life.
Earlier treatment: People cannot join if they had a knee replacement, other surgery, or hyaluronidase injection in the affected knee in the past 6 months. They must not use or start opioid or non-opioid pain medicines. They must stop other knee treatments such as TENS, electronic muscle stimulation or traditional ultrasound during the study.

Main reasons for not taking part

Pregnancy
Pacemaker, or unable to walk
Cancer, active infection, open sores or wounds, or reduced feeling in the treatment area
Known nerve disease, inherited tendency to heavy bleeding, or arthritis from a metabolic or inflammatory cause
Currently taking steroids, or allergy to corticosteroids or Kenalog®-40

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

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)

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 65 and 85 years old?

Where in United States

Cayuga Medical Center - Medical Pain ConsultantsDryden, United StatesContact: Ralph Ortiz, DO, MPHNot yet recruiting
Orthopaedic FoundationStamford, United StatesContact: Stephanie Petterson, PhD, MPTNot yet recruiting

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

SAM Ultrasound Device and Diclofenac PatchTreatment being tested
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts/cm\^2 intensity.
Treatment: Sustained Acoustic Device with 2.5% Diclofenac Patch
SAM Ultrasound Device and SAM PatchExisting treatment, for comparison
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with SAM patch (0% diclofenac).
Treatment: Sustained Acoustic Device with 0% Diclofenac Patch
Corticosteroid InjectionExisting treatment, for comparison
Patients receive treatment of single intraarticular corticosteroid injection (triamcinolone acetonide)
Treatment: Intra articular injection