A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis (PLUS+OA)

VA Office of Research and Development

Status and phase

Completed

Phase 2

Phase 1

Conditions

Osteoarthritis, Degenerative

Treatments

Device: Sham Comparator

Device: Pulsed Low Intensity Ultrasound

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02034409

CXI01CX000954-01A1 (Other Identifier)

CLIN-006-13S

Details and patient eligibility

About

The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.

Full description

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.

Enrollment

140 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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