Summary

for people ages 40 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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.

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.

Keywords

Osteoarthritis, Degenerative Knee Osteoarthritis Pulsed Low Intensity Ultrasound Osteoarthritis Sham Comparator PLIUS

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • VA San Diego Healthcare System, San Diego, CA accepting new patients
    San Diego California 92161 United States
  • VA Salt Lake City Health Care System, Salt Lake City, UT accepting new patients
    Salt Lake City Utah 84148 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT02034409
Phase
Phase 1/2
Study Type
Interventional
Last Updated