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

Not yet recruiting

• Conditions: Central Sensitisation; Postoperative Pain; Arthritis
• Interventions: Procedure: Total knee arthroplasty

• Registration Number: NCT06553118
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-10
• Study First Submitted QC: 2024-08-10
• Study Start: 2024-08-12
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-08-12
• Study Completion: 2026-02-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central Sensitization Group	Total knee arthroplasty	Patients with central sensitization
Non-sensitized Group	Total knee arthroplasty	Patients without central sensitization

Primary Outcome Measures

Name	Time	Method
Knee pain	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 Outcome Measures

Name	Time	Method
Functional Status	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.