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Clinical Trials/NCT00858416
NCT00858416
Completed
Phase 4

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

Kineticure1 site in 1 country71 target enrollmentApril 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Kineticure
Enrollment
71
Locations
1
Primary Endpoint
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,
Status
Completed
Last Updated
17 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
March 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Kineticure

Eligibility Criteria

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

Outcomes

Primary Outcomes

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,

Time Frame: 10 weeks

Secondary Outcomes

  • 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 Sites (1)

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