Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis

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 * 45-85 years of age * Report a frequent pain score between 3-7 (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 1% diclofenac gel provided to the subject at the initiation of the study * Deemed appropriate by their physician or by the study site physician to participate 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 severe OA or have little to no cartilage in the knee * Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months * Are non-ambulatory * Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening * Modify their medications during the course of the study (medications and doses must remain constant throughout the study) * Currently taking steroids * Have contraindication to radiograph * Have a secondary cause of arthritis (metabolic or inflammatory)