A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02034409
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	VA Office of Research and Development
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel O Clegg, MD
Principal Investigator Affiliation	VA Salt Lake City Health Care System, Salt Lake City, UT
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	U.S. Fed
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Degenerative

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Diego, California

Status

Recruiting

Address

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161

Site Contact

Susan Lee, MD

[email protected]

858-552-8585 #6148

Dallas, Texas

Status