- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01018277
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function
April 19, 2012 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function After Total Knee Arthroplasty: A Prospective, Consecutive, Trial
Aim of the present study is twofold.
- First we want to evaluate the effect of mobilization on acute postoperative pain
- Second to test weather chances in pain sensitivity are occurring following surgery and mobilization after total knee arthroplasty
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Little is known about the effect of mobilization on acute postoperative pain and mobilization induced pain, and if altered pain sensitivity occur under these circumstances.
- First we want to evaluate the effect of mobilization on acute postoperative pain using the visual analog scale (VAS)
- Second to test weather chances in pain sensitivity are occurring following surgery and mobilization after total knee arthroplasty, using two simple tools, the Pain Matcher and a Pressure Algometer.
Study Type
Observational
Enrollment (Actual)
26
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
-
-
Hvidovre
-
Copenhagen, Hvidovre, Denmark
- Hvidovre University Hospital
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Patients operated with TKA
Description
Inclusion Criteria:
- Patients scheduled for total unilateral knee arthroplasty
Exclusion Criteria:
- Cognitive dysfunction or peripheral / central neurological dysfunction inconsistent with protocol completing
- Alcohol and medical abuse (as defined by the National Health Service of Denmark
- Daily use of opioids or glucocorticoids
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score on the visual analog scale (difference before and after two mobilisation seances)
Time Frame: up to 24 hours
|
pain at rest (supine) 5 min after exercise(after the 2nd walk)
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score on the visual analog scale (difference before and after two mobilisation seances)
Time Frame: up to 24 hours
|
pain at rest (supine) 20 min after the 2nd walk, pain during passive hip flexion and pain during passive knee flexion 5 and 20 min after the 2nd walk, as well as pain during the 2nd walk after 6 and 25 m
|
up to 24 hours
|
|
Pain sensitivity measured with pressure algometry and with pain matcher (difference before and after two mobilisation seances and difference before and after surgery)
Time Frame: up to 24 hours
|
Nociceptive function before and after postoperative exercise
|
up to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
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
December 1, 2009
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
November 20, 2009
First Submitted That Met QC Criteria
November 20, 2009
First Posted (ESTIMATE)
November 23, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 20, 2012
Last Update Submitted That Met QC Criteria
April 19, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-1-2009-115
- 2009-41-4004
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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