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NCT Number: NCT06553118

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty

Procedure

Patients already admitted for total knee arthroplasty for knee osteoarthritis will have the procedure as planned

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Berk Korkut

CONTACT

[email protected]

+905305202866

Fatma Merih Akpınar

CONTACT

[email protected]

+905333558843

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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