Knee Joint Icing and Knee-extension Strength (IS)
This study has been terminated.
Sponsor:
Hvidovre University Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | November 23, 2010 | ||||
| Last Updated Date | July 18, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01249612 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Knee Joint Icing and Knee-extension Strength | ||||
| Official Title ICMJE | No Effect of Knee Joint Icing on Knee-extension Strength After Total Knee Arthroplasty. A Randomized Cross-over Study | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Arthroplasty | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Holm B, Husted H, Kehlet H, Bandholm T. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study. Clin Rehabil. 2012 Aug;26(8):716-23. Epub 2012 Jan 19. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01249612 | ||||
| Other Study ID Numbers ICMJE | (H-A-2008-063, nr. 24100, TKA-BH3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bente Holm, Hvidovre University Hospital | ||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||
| Collaborators ICMJE | Lundbeck Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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