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Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018277
First Posted: November 23, 2009
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
  Purpose

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

Condition Intervention Phase
Pain, Postoperative Pain Sensitivity, Postoperative Other: Mobilization (walking) Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function After Total Knee Arthroplasty: A Prospective, Consecutive, Trial

Further study details as provided by Troels Haxholdt Lunn, Hvidovre University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 26
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Mobilization (walking)
    25 meters twice
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients operated with TKA
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018277


Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Troels Haxholdt Lunn, MD Hvidovre University Hospital
  More Information

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01018277     History of Changes
Other Study ID Numbers: H-1-2009-115
2009-41-4004
First Submitted: November 20, 2009
First Posted: November 23, 2009
Last Update Posted: April 20, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms