Reliability and Validity of Physical Tests and Musculoskeletal Ultrasound As an Add-on in Classifying Anterior Knee Pain

NCT ID: NCT06904352

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-10-01

Brief Summary

Musculoskeletal ultrasound (MSU) or sonography is a non-invasive diagnostic technique and can extend the clinical examination of Anterior Knee Pain by visualizing musculoskeletal pathology to detect invisible flaws, it is safe, cheap and easy to use in primary care and therefore ensuring substitution of care. The European Society of Musculoskeletal Radiology (ESSR) has concluded that MSU can accurately classify APK pathologies. Protocol-based MSU can detect pathologic changes including cartilage swelling, fragmentation of the tibial tubercle ossification center, patellar tendon lesions, and reactive bursitis of the deep or superficial tibial patellar bursae and is increasingly used by physical therapists in the diagnostic process.

It is hypothesized that the validity of the physical examination is insufficient to accurately classify different conditions in AKP in patients aged 7-50 years. Therefore the use of MSU as an add-on is essential.

The purpose of this study is at first to assess the validity of the physical examination and second to evaluate the inter-rater reliability of protocol-based MSU and physical examination, in patients with AKP, in primary care physiotherapy.

The study is a cross-sectional observational study with four measurements within 60 minutes, without any intervention, performed with a single-gate diagnostic design with the same eligibility criteria for all participants including one group for comparison and measurement. The Strengthening the Reporting of Observational Studies in Epidemiology Statement was used as a guideline.

Detailed Description

Data will be collected from April 2025 to November 2025 in two multidisciplinary healthcare centers in the Netherlands, Amsterdam and Amersfoort. All confidential records were stored in a secure area with access only to JMH and HvdP, who also prepared the database for data analysis, to guarantee anonymity and confidential input of all data. In all participants, the sequence of measurements was identical. Pseudo anonymization was done by using the initials of the examiners and inclusion number.

Confidentiality and anonymity were guaranteed by storing all records in a secure area, and an encrypted electronic database was used for all encoded data. Patient Reported Outcomes Measures (PROMs) and physical tests are to be administered during the same time of day. They followed a predetermined order as outlined on the data registration form.

Conditions

Anterior Knee Pain Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients with on-traumatic anterior knee pain in primary care physiotherapy and general practice

No interventions will be applied

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All consecutive patients presenting clinical symptoms of AKP were screened for eligibility.

Exclusion Criteria

• patients with knee effusion, patients having patella instability, surgeries or previous fractured knee joint in the past, systemic pathology including inflammatory joint disease, and patients with interventions in the last three months including corticosteroid injection or physiotherapy.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Joannes M Hallegraeff

Dr. in clinical epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joannes M Hallegraeff, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Joannes Marinus Hallegraeff, MSc, PhD

Role: CONTACT

Joannes.Marinus.Hallegraeff@vub.be

0031655955742

Henk van der Pijl, MSc

Role: CONTACT

henkvdpijl@gmail.com

0031654388676

Other Identifiers

Vrije Universiteit Brussel

Identifier Type: OTHER

Identifier Source: secondary_id

24361 AKP

Identifier Type: -

Identifier Source: org_study_id