Skip to main content
OpenTrials
Completed

NCT Number: NCT00858416

Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Pain Musculoskeletal Diseases Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jacksonville Orthopedic Institute

Jacksonville, Florida, 32207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Kineticure System" followed by sham

Device

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

Other names: Kineticure System

sham followed by "Kineticure System"

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)

Other names: kineticure system

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,

    Time frame: 10 weeks

Secondary outcomes

  1. satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale

    Time frame: 10 weeks

  2. range of motion (ROM) of the knee (using goniometer)

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Kineticure

Industry

Registry information

Official study title

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

Acronym: KC-01

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 9, 2009
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.