Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
March 29, 2016 updated by: CDursteler, Parc de Salut Mar
This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain).
Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST).
Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08003
- Servicio d'Anestesia i Reanimació, Hospital del Mar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with knee osteoarthritis scheduled for total knee artheroplasty.
Description
Inclusion Criteria:
- Older than 18 patients
- Scheduled for primary total knee arthroplasty
- Disposition to visits and scheduled tests
Exclusion Criteria:
- Previous surgery on knee to be operated
- Documented peripheral neuropathy
- Severe disease or condition that could potentially interfere with interpretation of tests.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with knee osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Presence of pain in the operated knee, 6 months after surgery.
Time Frame: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
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Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.
Time Frame: From start of recruitment untill day 180.
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From start of recruitment untill day 180.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
March 13, 2013
First Submitted That Met QC Criteria
March 13, 2013
First Posted (ESTIMATE)
March 15, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 29, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKAPAIN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.