Effect of Mobilization on Acute Postoperative Pain and No... | NCT01018277

Studies
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function

NCT01018277

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Apr 20, 2012Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Pain, Postoperative
Pain Sensitivity, Postoperative

Interventions

Mobilization (walking)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-41-4004

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Nov 20, 2009

First Submission Date that Met QC Criteria

Nov 20, 2009

First Posted Date

Nov 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2012

Last Update Posted Date

Apr 20, 2012Estimated

Name	Class
Lundbeck Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Name	Type	Description	Arm Group Labels	Other Names
Mobilization (walking)	Other	25 meters twice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients operated with TKA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Troels Haxholdt Lunn, MD	Hvidovre University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre University Hospital		Copenhagen	Hvidovre		Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016138	Walking

Ancestor Terms

ID	Term
D008124	Locomotion
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided