Patellofemoral Pain Syndrome Clinical Trial
Official title:
Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS (KOOS PF)
Verified date | September 2023 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | September 20, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | first day | |
Primary | 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 | first day | |
Primary | 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. | first day | |
Primary | 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). | 7-14 days after | |
Primary | 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). | 3 months after | |
Primary | 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). | 3 months after |
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