Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis

NCT ID: NCT00858416

Last Updated: 2009-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Knee Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AB

First active then Sham

Group Type EXPERIMENTAL

"Kineticure System" followed by sham

Intervention Type 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

BA

First sham then active

Group Type SHAM_COMPARATOR

sham followed by "Kineticure System"

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"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

Intervention Type 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)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kineticure System kineticure system

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kineticure

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jacksonville Orthopedic Institute

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gary S Kitay, MD

Role: PRINCIPAL_INVESTIGATOR

Jacksonville Orthopedic Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jacksonville Orthopedic Institute

Jacksonville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.

Reference Type DERIVED
PMID: 19433134 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KC-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.