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

  • Spain
      • Barcelona, Spain, 08003
        • Servicio d'Anestesia i Reanimació, Hospital del Mar

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
Patients with knee osteoarthritis
Behavioral: Quantitative sensory testing (QST)

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.
Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

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.
From start of recruitment untill day 180.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

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.

General Publications

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.

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