Patellofemoral Pain SyndromeNCT06060730
Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
An observational study of Patellofemoral Pain Syndrome and Patellofemoral Osteoarthritis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Patellofemoral Osteoarthritis, PROMs
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2018to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with patellofemoral pain and OA
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Patellofemoral Pain Syndrome, Patellofemoral Osteoarthritis, Patient-reported outcome measures, PROMs, Validity, Reliability
- Medical subject headings
- Patellofemoral Pain Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
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).
Measured: first day
the Kujala's Anterior Pain Scale (AKPS)
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
Measured: first day
the Short Form-36 health survey (SF-36)
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.
Measured: first day
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
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).
Measured: 7-14 days after
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF)
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).
Measured: 3 months after
the global rating of change (GROC)
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).
Measured: 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start20 Sep 2018
- Primary completion30 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Beyza Ölmez, Gazi University
- Investigators
- Selda Başar, Prof, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060730
- Sponsor's protocol ID
- 2023 - 986
- Status last verified
- Sep 2023
- First submitted
- 24 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS (KOOS PF)
- ClinicalTrials.gov ID
- NCT06060730
- Acronym / sponsor ID
- 2023 - 986
- Keywords
- Patellofemoral Pain Syndrome, Patellofemoral Osteoarthritis, Patient-reported outcome measures, PROMs, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with patellofemoral pain and OA
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
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.
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Başar, Prof study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome and Patellofemoral Osteoarthritis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) (time frame: first day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.