Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01018277
First received: November 20, 2009
Last updated: April 19, 2012
Last verified: April 2012
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 20, 2009
Last Updated: April 19, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014