Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis
NCT ID: NCT00858416
Last Updated: 2009-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
71 participants
INTERVENTIONAL
2006-04-30
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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AB
First active then Sham
"Kineticure System" followed by sham
20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device
BA
First sham then active
sham followed by "Kineticure System"
sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
Interventions
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"Kineticure System" followed by sham
20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device
sham followed by "Kineticure System"
sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptoms consistent with radiographic OA grades 2, 3 or 4 by Kellgren and Lawrence criteria
* moderate to severe knee pain (≥35mm on a 100mm visual analog pain scale (VAS)).
Exclusion Criteria
45 Years
80 Years
ALL
No
Sponsors
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Kineticure
INDUSTRY
Responsible Party
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Jacksonville Orthopedic Institute
Principal Investigators
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Gary S Kitay, MD
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Orthopedic Institute
Locations
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Jacksonville Orthopedic Institute
Jacksonville, Florida, United States
Countries
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References
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Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
Other Identifiers
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KC-01
Identifier Type: -
Identifier Source: org_study_id
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