Pain, PostoperativeNCT01018277
Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function
An observational study of Pain, Postoperative and Pain Sensitivity, Postoperative, run by Hvidovre University Hospital at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain Sensitivity, Postoperative
- What is being tested?
- Mobilization (walking)
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated with TKA
Who may be able to join
- Patients scheduled for total unilateral knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Mobilization (walking)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization (walking)Other
25 meters twice
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 24 hours
Secondary outcomes (2)
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
Measured: 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)
Nociceptive function before and after postoperative exercise
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
- Investigators
- Troels Haxholdt Lunn, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018277
- Sponsor's protocol ID
- H-1-2009-115
- Other IDs
- 2009-41-4004
- Status last verified
- Apr 2012
- First submitted
- 20 Nov 2009
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobilization on Acute Postoperative Pain and Nociceptive Function After Total Knee Arthroplasty: A Prospective, Consecutive, Trial
- ClinicalTrials.gov ID
- NCT01018277
- Acronym / sponsor ID
- H-1-2009-115
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated with TKA
Key inclusion criteria (1 listed)
- Patients scheduled for total unilateral knee arthroplasty
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization (walking)25 meters twice | Other | – |
Primary outcome
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)
2 secondary outcomes
Pain score on the visual analog scale (difference before and after two mobilisation seances)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels Haxholdt Lunn, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Pain Sensitivity, Postoperative, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on the visual analog scale (difference before and after two mobilisation seances) (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.