Knee Joint Icing and Knee-extension Strength (IS)

July 18, 2012 updated by: Bente Holm, Hvidovre University Hospital

No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study

With this study the investigators wish to (1) investigate the acute effect of knee joint icing on knee-extension strength shortly after total knee arthroplasty (TKA); and (2) investigate the acute effect of knee joint icing on knee pain, knee joint circumference and functional performance shortly after TKA.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

As knee joint icing had no acute effect on knee-extension strength in the present study, prolonged icing may have an effect on one or more of the parameters, and further studies are needed to determine the potential beneficial effects of cooling after TKA.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • The Lundbeckcenter for fast-track hip and knee surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary unilateral total knee arthroplasty

Exclusion Criteria:

  • inability to speak and understand Danish
  • inability to perform the measurements due to other diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control treatment
Elbow joint icing using two plastic bags with crushed ice
Other: Thermotherapy
Knee joint icing
Other Names:
  • Cryotherapy
Other: Thermotherapy
Elbow joint icing
Other Names:
  • Cryotherapy
Active Comparator: Active treatment
Knee joint icing using two plastic bags with crushed ice
Other: Thermotherapy
Knee joint icing
Other Names:
  • Cryotherapy
Other: Thermotherapy
Elbow joint icing
Other Names:
  • Cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee-extension strength
Time Frame: In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment
Maximal knee-extension strength is measured using a hand-held dynamometer
In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee pain
Time Frame: In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment
Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements.
In the first week after surgery patients are measured on two days: One day before and after active (knee icing) treatment and one day before and after control (elbow icing) treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Lundbeck Foundation

Investigators

  • Principal Investigator: Bente Holm, MSc, Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • (H-A-2008-063, nr. 24100
  • TKA-BH3 (Registry Identifier: H-A-2008-063)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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