Knee Joint Icing and Knee-extension Strength (IS)

This study has been terminated.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Bente Holm, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01249612
First received: November 23, 2010
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Arthroplasty
Other: Thermotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Maximal knee-extension strength is measured using a hand-held dynamometer


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Knee pain was quantified by using The Visual Analog Scale (VAS) at rest and during active measurements.


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control treatment
Elbow joint icing using two plastic bags with crushed ice
Other: Thermotherapy
Elbow joint icing
Other Name: Cryotherapy
Active Comparator: Active treatment
Knee joint icing using two plastic bags with crushed ice
Other: Thermotherapy
Knee joint icing
Other Name: Cryotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary unilateral total knee arthroplasty

Exclusion Criteria:

  • inability to speak and understand Danish
  • inability to perform the measurements due to other diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249612

Locations
Denmark
The Lundbeckcenter for fast-track hip and knee surgery
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Bente Holm, MSc Department of Orthopaedic Surgery, University Hospital at Hvidovre, Kettegaard Alle 30, DK-2650 Hvidovre, Denmark
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bente Holm, MSc PT, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01249612     History of Changes
Other Study ID Numbers: (H-A-2008-063, nr. 24100, TKA-BH3
Study First Received: November 23, 2010
Last Updated: July 18, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
Knee joint icing
knee-extension strength

ClinicalTrials.gov processed this record on August 28, 2014