Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery

August 13, 2024 updated by: Fatma Merih Akpınar, Istanbul University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis

Description

Inclusion Criteria:

  • Diagnosis of primary knee osteoarthritis
  • Planning for total joint replacement surgery for the knee
  • Being between the ages of 60-75

Exclusion Criteria:

  • 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

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
Central Sensitization Group
Patients with central sensitization
Procedure: Total knee arthroplasty
Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned
Non-sensitized Group
Patients without central sensitization
Procedure: Total knee arthroplasty
Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee pain
Time Frame: Preoperative, 1 month postoperative and 3 months postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Status
Time Frame: Preoperative, 1 month postoperative and 3 months postoperative
Functionality of the patients will be assessed with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index). Responses are typically rated on a scale from 0 (none) to 4 (extreme). Higher scores indicate greater impairment.
Preoperative, 1 month postoperative and 3 months postoperative

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Fatma Merih Akpınar, Istanbul Faculty of Medicine

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 (Estimated)

August 12, 2024

Primary Completion (Estimated)

August 12, 2025

Study Completion (Estimated)

February 12, 2026

Study Registration Dates

First Submitted

August 10, 2024

First Submitted That Met QC Criteria

August 10, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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