A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

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.

Inclusion Criteria:

- 40 years of age or older, and a US Military Veteran

- Clinical symptoms of osteoarthritis for at least 6 months

- Pain in the index knee on motion or weight bearing for the majority of days during the
month before screening

- Clinical diagnosis of primary osteoarthritis of the knee based on clinical and
radiographic criteria

- American Rheumatism Association Functional Class I, II, or III

- Females of childbearing potential must be willing to use a reliable form of medically
acceptable contraception

Exclusion Criteria:

- Concurrent medical/arthritis condition(s), or any other illness per the opinion of the
investigator, that could interfere with the evaluation of pain or efficacy

- Spine or hip pain of significant magnitude

- History of significant ligament or meniscal injury of the index joint requiring
surgical repair

- Arthroscopy of the index knee within 6 months of study entry

- Unable to undergo MRI of the knee

- Pregnancy or lactation

- Corticosteroid treatment within 1 to 3 months prior to study entry

- Intra-articular injection of hyaluronic acid or congeners to the index knee within 6
months of study entry

- Use of excluded therapy(ies) prior to study entry

- Use of disease modifying anti-rheumatic medications and chronic tetracycline or its
derivatives

- Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment,
within 1 month of study entry

- Use of any medical therapy, complementary or alternative regimens for the treatment of
osteoarthritis within 7 days prior to study entry

- Initiation of physical therapy or muscle conditioning program to the lower extremities
within 2 months within 2 months prior to study entry

- Unlikely to comply with study requirements