Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS

September 29, 2023 updated by: Sevim Beyza Ölmez, Gazi University

Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS (KOOS PF)

The purpose of this study is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to determine the measurement properties of the Turkish version.

Study Overview

Status

Completed

Conditions

Detailed Description

Patellofemoral pain and patellofemoral osteoarthritis are highly prevalent knee disorders associated with pain and functional limitations. Patient-reported outcome measures (PROMs) are suggested for clinical and research use; however, there is a lack of objective disease-specific PROMs for patellofemoral pain and osteoarthritis. The purpose of this study is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to determine the measurement properties of the Turkish version.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

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

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University

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

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with patellofemoral pain and OA

Description

Inclusion Criteria:

  • peripatellar or retropatellar knee pain persisting for at least 3 months and exacerbated by activities that load the patellofemoral joint;
  • pain intensity of at least 3 mm according to the visual analogue scale (VAS)

Exclusion Criteria:

  • diffuse or generalized knee pain
  • severe trauma to the target knee in the previous year
  • moderate to severe concomitant tibiofemoral osteoarthritis
  • recent knee injection (within 3 months)
  • systemic inflammatory conditions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
Time Frame: first day
The subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) is a disease-specific PROM designed to evaluate pain, stiffness, and quality of life in patients with patellofemoral pain and/or osteoarthritis. It has 11 items that assess three domains: stiffness (1 item), pain (9 items), and quality of life (1 item). Each item consists of five response options with a score between 0 and 4. The total score ranges from 0 (worst) to 100 (best).
first day
the Kujala's Anterior Pain Scale (AKPS)
Time Frame: first day
The Kujala's Anterior Pain Scale (AKPS) is a self-administered questionnaire designed for patellofemoral disorders. It consists of 13 items on symptoms and functional limitations. The total score ranges from 0 to 100, with higher values indicating less functional status
first day
the Short Form-36 health survey (SF-36)
Time Frame: first day
The short-form 36 (SF-36) health survey is a tool for assessing general health-related quality of life. It consists of 36 questions divided into eight domains, which are then merged under two large headings: physical component summary and mental component summary. The total score varies between 0 and 100. Higher ratings indicate a better quality of life.
first day
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
Time Frame: 7-14 days after
The subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) is a disease-specific PROM designed to evaluate pain, stiffness, and quality of life in patients with patellofemoral pain and/or osteoarthritis. It has 11 items that assess three domains: stiffness (1 item), pain (9 items), and quality of life (1 item). Each item consists of five response options with a score between 0 and 4. The total score ranges from 0 (worst) to 100 (best).
7-14 days after
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
Time Frame: 3 months after
The subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) is a disease-specific PROM designed to evaluate pain, stiffness, and quality of life in patients with patellofemoral pain and/or osteoarthritis. It has 11 items that assess three domains: stiffness (1 item), pain (9 items), and quality of life (1 item). Each item consists of five response options with a score between 0 and 4. The total score ranges from 0 (worst) to 100 (best).
3 months after
the global rating of change (GROC)
Time Frame: 3 months after
The global rating of change (GROC) score is a single-item questionnaire with five potential responses depending on the patient's change in knee pain following the initial assessment. Likert scale with five response options: "0 points" (much worse), "1 points" (slightly worse), "2 points" (about the same), "3 points" (slightly better), and "4 points" (much better).
3 months after

Collaborators and Investigators

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

Sponsor

Gazi University

Investigators

  • Study Chair: Selda Başar, Prof, Gazi University

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 (Actual)

September 20, 2018

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 - 986

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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