Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
1 other identifier
observational
80
0 countries
N/A
Brief Summary
The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery. The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis. When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.
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 Aug 2024
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
First Submitted
Initial submission to the registry
August 10, 2024
CompletedStudy Start
First participant enrolled
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2026
CompletedAugust 15, 2024
August 1, 2024
1 year
August 10, 2024
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Knee pain
Knee pain will be assessed with numerical rating scale, where the patients rate their pain on a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain they can imagine.
Preoperative, 1 month postoperative and 3 months postoperative
Secondary Outcomes (1)
Functional Status
Preoperative, 1 month postoperative and 3 months postoperative
Study Arms (2)
Central Sensitization Group
Patients with central sensitization
Non-sensitized Group
Patients without central sensitization
Interventions
Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned
Eligibility Criteria
The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis
You may qualify if:
- Diagnosis of primary knee osteoarthritis
- Planning for total joint replacement surgery for the knee
- Being between the ages of 60-75
You may not qualify if:
- Having secondary knee osteoarthritis
- Planning for knee total joint prosthesis revision
- Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)
- Having neuromuscular disease
- Having a body mass index over 40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatma Merih Akpınar
Istanbul Faculty of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2024
First Posted
August 14, 2024
Study Start
August 12, 2024
Primary Completion
August 12, 2025
Study Completion
February 12, 2026
Last Updated
August 15, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share