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

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT06060730
Collaborator
(none)
55
1
60
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    55 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS (KOOS PF)
    Actual Study Start Date :
    Sep 20, 2018
    Actual Primary Completion Date :
    Aug 30, 2023
    Actual Study Completion Date :
    Sep 20, 2023

    Outcome Measures

    Primary Outcome Measures

    1. the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) [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).

    2. the Kujala's Anterior Pain Scale (AKPS) [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

    3. the Short Form-36 health survey (SF-36) [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.

    4. the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) [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).

    5. the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) [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).

    6. the global rating of change (GROC) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Ankara Turkey

    Sponsors and Collaborators

    • Gazi University

    Investigators

    • Study Chair: Selda Başar, Prof, Gazi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sevim Beyza Ölmez, Principal investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT06060730
    Other Study ID Numbers:
    • 2023 - 986
    First Posted:
    Sep 29, 2023
    Last Update Posted:
    Oct 3, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sevim Beyza Ölmez, Principal investigator, Gazi University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 3, 2023