Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function

Pain, Postoperative Clinical Trial

Official title:

Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function After Total Knee Arthroplasty: A Prospective, Consecutive, Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018277
• Other study ID #: H-1-2009-115
• Secondary ID: 2009-41-4004
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2009
• Last updated: April 19, 2012
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain Sensitivity, Postoperative
• Pain, Postoperative

Intervention

Other:
• Mobilization (walking)
25 meters twice

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on the visual analog scale (difference before and after two mobilisation seances)	pain at rest (supine) 5 min after exercise(after the 2nd walk)	up to 24 hours	No
Secondary	Pain score on the visual analog scale (difference before and after two mobilisation seances)	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	No
Secondary	Pain sensitivity measured with pressure algometry and with pain matcher (difference before and after two mobilisation seances and difference before and after surgery)	Nociceptive function before and after postoperative exercise	up to 24 hours	No