Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis

Phase 4

Completed

• Conditions: Osteoarthritis; Knee Pain
• Interventions: Device: "Kineticure System" followed by sham; Device: sham followed by "Kineticure System"

• Registration Number: NCT00858416
• Lead Sponsor: Kineticure

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-06
• Last Update Submitted: 2009-03-06
• Study First Posted: 2009-03-09
• Last Update Posted: 2009-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AB	"Kineticure System" followed by sham	First active then Sham
BA	sham followed by "Kineticure System"	First sham then active

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jacksonville Orthopedic Institute; 🇺🇸 Jacksonville, Florida, United States