Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis

Osteoarthritis Clinical Trial

— KC-01  

Official title:

Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858416
• Other study ID #: KC-01
• Status: Completed
• Phase: Phase 4
• First received: March 2, 2009
• Last updated: March 6, 2009
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2009
• Source: Kineticure
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)).

Exclusion Criteria:

• knee or hip surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Pain
• Osteoarthritis

Intervention

Device:
• "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)

Locations

Country	Name	City	State
United States	Jacksonville Orthopedic Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kineticure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale		10 weeks	No
Secondary	range of motion (ROM) of the knee (using goniometer)		10 weeks	No