Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

Inclusion Criteria: * Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months * Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA * 35-80 years of age * Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment * Report that knee pain negatively affects quality of life * 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 * Deemed appropriate by their physician or by the study site physician to participate * 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 initiate use of opioid and/or non-opioid analgesic medications * Willing to discontinue any other interventional treatment modalities on the knee during the study period Exclusion Criteria: * Cannot successfully demonstrate the ability to put on and take off the device * Display 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 * Have sever…