Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis
KC-01
Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee
1 other identifier
interventional
71
1 country
1
Brief Summary
The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion and heat on the severity of pain in management of osteoarthritis of the knee
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedMarch 9, 2009
March 1, 2009
11 months
March 2, 2009
March 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
intensity of pain as measured on a 100 mm non-marked VAS and the total Western Ontario McMaster (WOMAC) OA index using a Likert scale,
10 weeks
Secondary Outcomes (2)
satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale
10 weeks
range of motion (ROM) of the knee (using goniometer)
10 weeks
Study Arms (2)
AB
EXPERIMENTALFirst active then Sham
BA
SHAM COMPARATORFirst sham then active
Interventions
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 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)
Eligibility Criteria
You may qualify if:
- diagnosis of OA of the knee by ACR 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)).
You may not qualify if:
- knee or hip surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kineticurelead
Study Sites (1)
Jacksonville Orthopedic Institute
Jacksonville, Florida, 32207, United States
Related Publications (1)
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.
PMID: 19433134DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary S Kitay, MD
Jacksonville Orthopedic Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 9, 2009
Study Start
April 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 9, 2009
Record last verified: 2009-03