Using ultrasound to relieve osteoarthritis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of Sustained Acoustic Medicine, a continuous ultrasound treatment, to a topical pain relief gel for managing symptoms of osteoarthritis. Participants will be assessed for pain and functional improvement while receiving either treatment. The study focuses on individuals with mild to moderate osteoarthritis in various joints, including the knee and shoulder. The goal is to determine which method provides better relief from pain and enhances quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

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.
* 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's running

• James A Haley Veterans Hospital
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Sandra Winkler, Ph.D. — James A. Haley Veterans Hospital
• Study coordinator: George K. Lewis, Ph.D.
• Email: george@zetroz.com
• Phone: 888-202-9831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.