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

HF-01

The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

2019-09-01

2019-12-31

2019-12-31

Completed

Early phase I

34

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2023-06-27