Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
1 other identifier
observational
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 31, 2016
March 1, 2016
2.9 years
March 13, 2013
March 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of pain 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 Outcomes (1)
Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.
From start of recruitment untill day 180.
Study Arms (1)
Patients with knee osteoarthritis
Interventions
Eligibility Criteria
Patients with knee osteoarthritis scheduled for total knee artheroplasty.
You may qualify if:
- Older than 18 patients
- Scheduled for primary total knee arthroplasty
- Disposition to visits and scheduled tests
You may not qualify if:
- Previous surgery on knee to be operated
- Documented peripheral neuropathy
- Severe disease or condition that could potentially interfere with interpretation of tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Servicio d'Anestesia i Reanimació, Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Related Publications (1)
Dursteler C, Salazar Y, Rodriguez U, Pelfort X, Verdie LP. Conditioned pain modulation predicts persistent pain after knee replacement surgery. Pain Rep. 2021 Mar 29;6(1):e910. doi: 10.1097/PR9.0000000000000910. eCollection 2021 Jan-Feb.
PMID: 33817538DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 13, 2013
First Posted
March 15, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 31, 2016
Record last verified: 2016-03