Could a wearable ultrasound device ease knee arthritis pain without pills?
NCT ID NCT06257537
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests a wearable device that delivers low-intensity ultrasound to the knee for 1-4 hours daily, combined with a diclofenac pain patch, to reduce pain and improve function in people with mild-to-moderate knee osteoarthritis. Participants aged 50-85 with frequent knee pain will use the device at home over 24 weeks. The goal is to see if this long-duration ultrasound treatment can provide lasting pain relief and better joint mobility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sustained acoustic medicine device with 2.5% diclofenac patch
- What this could lead to
- If it works, this could offer a non-invasive, drug-free option for managing knee osteoarthritis pain and improving mobility without surgery or daily pills.
- What could go wrong
- This is a Phase 2 trial, so results are still early. The device may not provide significant pain relief, and some people may experience skin irritation from the patch or discomfort from the ultrasound.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
307 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 50-85 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 Criteria: * 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cayuga Medical Center - Medical Pain Consultants
Dryden, New York, 13053, United States
-
Orthopaedic Foundation
Stamford, Connecticut, 06905, United States
-
ZetrOZ Systems
Trumbull, Connecticut, 06611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Digital tools may help osteoarthritis patients avoid surgery
- Can shedding pounds reshape the legs? a study tracks joint alignment after Weight-Loss surgery
- Can body weight predict success of knee realignment surgery?
- Can better sleep ease pain in teens with rheumatic disease?
- Menthol and copaiba cream put to the test for joint pain relief
- Can a meditation practice curb Post-Surgery pain and opioid use?