Sustained Acoustic Medicine for Osteoarthritis Pain

Recruiting now · Phase 1

Conditions studied: Osteoarthritis

In brief

The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.

Key facts

Study ID

NCT05254574

Run by

ZetrOZ, Inc.

People needed

200

Starts

2022-02-14

Expected to finish

2026-05-31

Last updated by the study team

2025-02-27

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
• Are between 35-85 years of age
• Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
• Report that knee, shoulder, elbow, ankle, hip, or spine 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 treatment 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 opioid and/or non-opioid analgesic medications.
• Be willing to discontinue any other interventional treatment modalities on the treatment area 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.
• 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, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
• Requires oxygen support
• Has an allergy to aspirin or other NSAIDs
• Have a secondary cause of arthritis (metabolic or inflammatory)

Where it is running

• James A Haley Veterans Hospital — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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