Dryden

Researchers are evaluating the use of long-duration low intensity therapeutic ultrasound (LITUS) to reduce knee pain caused by osteoarthritis over a 24-week period. The main goal is to see how well LITUS relieves pain in people with knee osteoarthritis. The study also aims to assess whether LITUS can improve joint function and overall quality of life in these patients. This is a phase 2 clinical study involving adults aged 50 to 85 years with mild to moderate knee osteoarthritis. Participants will use the wireless Sustained Acoustic Medicine (SAM) device daily at home for 1 to 4 hours. The device delivers continuous therapeutic ultrasound at a frequency of 3 megahertz and intensity of 0.132 Watts/cm². There are different treatment groups: some use the SAM device combined with a 2.5% diclofenac patch, others use the SAM device with a 0% diclofenac patch, and some use only the patches or ultrasound gel. Treatments are self-applied daily for 24 weeks, with at least 5 days per week of patch use. Throughout the study, patients will record their pain levels daily before and after treatment. Assessments of joint function, quality of life, depression, anxiety, and sleep will be done at the start, and at 8, 16, and 24 weeks. Researchers will measure changes in pain using a scale from 0 (least pain) to 10 (worst pain), and use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to assess symptoms. The study includes safety monitoring and aims to recruit over 300 participants from both urban and rural communities.