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NCT06257862 Clinical Trial

Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale

Patellofemoral Pain Syndrome Clinical Trial

— Kujala-DK  

Official title:
Translation, Cross-cultural Validity and Reliability of a Danish Version of the Anterior Knee Pain Scale (Kujala-DK)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06257862
Other study ID # Questionnaire KUJALA-DK
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2027

Study information
Verified date February 2024
Source Aarhus University Hospital
Contact Torsten G Nielsen, MHSc
Phone +4540491184
Email torsne@rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation. The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 130
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 40 Years
Eligibility Inclusion Criteria: - Danish speaking - MPFL-reconstructed Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Division of Sports Trauma, Palle Juul-Jensens Boulevard 99 Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kujala (Anterior Knee Pain Scale) Patient reported outcome score. (0-100 (0 = Worst, 100 = Best) Baseline, after 6-8 days
Primary Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P) Patient reported outcome score. (0-100 (0 = Worst, 100 = Best) Baseline
Primary International knee documentation committee (IKDC) Patient reported outcome score. (0-100 (0 = Worst, 100 = Best) Baseline
Primary Banff patella instability instrument (BPII 2.0) Patient reported outcome score. (0-100 (0 = Worst, 100 = Best) Baseline
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