Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis - Full Text View

Sponsored by:	Kineticure
Information provided by:	Kineticure
ClinicalTrials.gov Identifier:	NCT00858416

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Knee Pain	Device: "Kineticure System" followed by sham Device: sham followed by "Kineticure System"	Phase IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Efficacy of Combined Local Mechanical Vibrations, Continuous Passive Motion and Thermotherapy in the Management of Osteoarthritis of the Knee

Further study details as provided by Kineticure:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

satisfaction of use of the Kineticure device as measured on a 0-100 mm non-marked scale [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
range of motion (ROM) of the knee (using goniometer) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	April 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AB: Experimental First active then Sham	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
BA: Sham Comparator First sham then active	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)

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858416

Locations

United States, Florida
Jacksonville Orthopedic Institute
Jacksonville, Florida, United States, 32207

Sponsors and Collaborators

Kineticure

Investigators

Principal Investigator:

Gary S Kitay, MD

Jacksonville Orthopedic Institute

More Information

No publications provided

Responsible Party:	Jacksonville Orthopedic Institute ( Dr. Garry S Kitay )
Study ID Numbers:	KC-01
Study First Received:	March 2, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858416 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Clotrimazole
Osteoarthritis
Miconazole
Antifungal Agents

Joint Diseases
Arthritis
Tioconazole
Salicylhydroxamic acid
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiprotozoal Agents
Osteoarthritis
Joint Diseases
Rheumatic Diseases
Pharmacologic Actions

Osteoarthritis, Knee
Antiparasitic Agents
Musculoskeletal Diseases
Arthritis
Antifungal Agents
Therapeutic Uses
Salicylhydroxamic acid

ClinicalTrials.gov processed this record on May 06, 2009