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A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis

NCT ID: NCT02034409

Last Updated: 2021-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-22

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis, Degenerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants in this double-blind, randomized, sham-controlled trial will be randomly assigned to receive either sham or PLIUS device for 48 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sham

Treatment to index knee with sham device for 48 weeks

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DEVICE

20 minutes daily for 48 weeks

PLIUS

Treatment to index knee with PLIUS device for 48 weeks

Group Type EXPERIMENTAL

Pulsed Low Intensity Ultrasound

Intervention Type DEVICE

20 minutes daily for 48 weeks

Interventions

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Pulsed Low Intensity Ultrasound

20 minutes daily for 48 weeks

Intervention Type DEVICE

Sham Comparator

20 minutes daily for 48 weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel O Clegg, MD

Role: PRINCIPAL_INVESTIGATOR

VA Salt Lake City Health Care System, Salt Lake City, UT

Locations

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VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Site Status

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Sawitzke AD, Jackson CG, Carlson K, Bizien MD, Leiner M, Reda DJ, Sindowski T, Hanrahan C, Spencer RG, Kwoh CK, Lee SJ, Hose K, Robin L, Cain DW, Taylor MD, Bangerter N, Finco M, Clegg DO. Effect of Pulsed Low-Intensity Ultrasonography on Symptom Relief and Tibiofemoral Articular Cartilage Thickness Among Veterans Affairs Enrollees With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220632. doi: 10.1001/jamanetworkopen.2022.0632.

Reference Type DERIVED
PMID: 35258579 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CXI01CX000954-01A1

Identifier Type: OTHER

Identifier Source: secondary_id

CLIN-006-13S

Identifier Type: -

Identifier Source: org_study_id