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

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ClinicalTrials.gov Identifier: NCT02034409
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Degenerative Device: Pulsed Low Intensity Ultrasound Device: Sham Comparator Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants in this double-blind, randomized, sham-controlled trial will be randomly assigned to receive either sham or PLIUS device for 48 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
Actual Study Start Date : May 29, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sham
Treatment to index knee with sham device for 48 weeks
Device: Sham Comparator
20 minutes daily for 48 weeks

Experimental: PLIUS
Treatment to index knee with PLIUS device for 48 weeks
Device: Pulsed Low Intensity Ultrasound
20 minutes daily for 48 weeks




Primary Outcome Measures :
  1. Co-Primary Measure: a) Symptom reduction [ Time Frame: 48 weeks ]
    Co-Primary Measure: a) Symptom reduction as measured by OMERACT-OARSI Responder Criteria

  2. Co-Primary Measure: b) Disease-modification [ Time Frame: 48 weeks ]
    Co-Primary Measure: b) Disease-modification as measured by MRI determined cartilage thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034409


Contacts
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Contact: Daniel O Clegg, MD (801) 582-1565 Daniel.Clegg@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Susan Lee, MD    858-552-8585 ext 6148    s2lee@ucsd.edu   
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: Andreas Reimold, MD    903-583-2111    andreas.reimold@va.gov   
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Julie Ann Hall, BA    801-584-1268      
Principal Investigator: Daniel O Clegg, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Daniel O Clegg, MD VA Salt Lake City Health Care System, Salt Lake City, UT

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02034409     History of Changes
Other Study ID Numbers: CLIN-006-13S
CXI01CX000954-01A1 ( Other Identifier: eRA project Reference )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Knee Osteoarthritis
Pulsed Low Intensity Ultrasound

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases