Clinical trial NCT02034409: A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
Official title: A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Degenerative
Keywords: Knee Osteoarthritis
Pulsed Low Intensity Ultrasound
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-01-13
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness
timeFrame: 48 weeks
measure: Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease
timeFrame: Baseline, 48 weeks
Secondary outcomes:
measure: Change From Baseline in WOMAC Stiffness Subscale Score
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in WOMAC Pain Subscale Score
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in WOMAC Functional Limits Subscale Score
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Total WOMAC Score
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Patient Global Assessment of Disease Status
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Investigator Global Assessment of Disease Status
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale
timeFrame: Baseline, week 24, week 48
measure: Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score
timeFrame: Baseline, week 24, week 48
measure: Number of Participants Discontinuing the Study Device Due to an Adverse Device Event
timeFrame: Baseline, 4, 8, 12, 24, 36, and 48-week visits
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
name: Daniel O Clegg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.