A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

Principal Investigator: Daniel O. Clegg, MD, Salt Lake City VA Medical Center
Co-Investigator/Steering Committee Member: C. Kent Kwoh, MD
Funding: U.S. Department of Veterans Affairs NCT02034409

Osteoarthritis (OA), the most common form of arthritis, is a prevalent and debilitating disease without therapies that alter disease progress and is currently managed with symptom-modifying therapies that are only modestly effective. In spite of substantial progress in understanding the pathogenesis of OA, no effective disease modifying interventions have been established. Degenerative joint cartilage is a central feature of OA, yet joint cartilage has a limited capacity for repair. Results from animal research demonstrate that pulsed low intensity ultrasound (PLIUS) mechanically stimulates, and may promote, cartilage repair. This exploratory trial will investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.

The study proposes a Phase IIa, multi-center, randomized, sham-controlled, parallel, double-blind trial to determine if pulsed low-intensity ultrasound (PLIUS) is potentially more effective than sham as a symptom- and structure-modifying intervention in patients with early OA of the knee. PLIUS will be applied using an FDA-approved device already in clinical use for bone fracture healing.

All patients will be followed in the treatment period for 48 weeks, which is the time point for assessment of the co-primary outcomes of symptom relief, as assessed by the OMERACT-OARSI Responder Criteria, and structural modification, as assessed by MRI-determined medial femoral condyle cartilage thickness. Participants are being recruited from three sites: VA San Diego Healthcare System; VA North Texas Health Care System at the Dallas VA Medical Center; and VA Salt Lake City Health Care System.