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Not yet recruitingNCT06553118Updated Aug 15, 2024

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

An observational study in Central Sensitisation, Postoperative Pain and Arthritis, sponsored by Istanbul University. Not yet recruiting. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Istanbul University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
60 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Central Sensitisation
  • Postoperative Pain
  • Arthritis

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 80 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 79 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Central Sensitization Group

    Patients with central sensitization

    Procedure: Total knee arthroplasty

  • Non-sensitized Group

    Patients without central sensitization

    Procedure: Total knee arthroplasty

Interventions

  • ProcedureTotal knee arthroplasty

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

06

What researchers measure

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.

    Time frame: Preoperative, 1 month postoperative and 3 months postoperative

Secondary outcomes

  1. Functional Status

    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.

    Time frame: Preoperative, 1 month postoperative and 3 months postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06553118
Lead sponsor
Istanbul University
Responsible party
Fatma Merih Akpınar (Assistant Professor, Istanbul University) — Principal investigator
First posted
Aug 14, 2024
Start date
Aug 12, 2024 (estimated)
Primary completion
Aug 12, 2025 (estimated)
Completion
Feb 12, 2026 (estimated)
Last update
Aug 15, 2024

Study contacts

Fatma Merih Akpınar
Contact
merihcaliskan@gmail.com
+905333558843
Berk Korkut
Contact
berkkorkut@windowslive.com
+905305202866
Fatma Merih Akpınar
principal investigator · Istanbul Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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