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

NCT06904352 | Not Yet Recruiting

• 2 other identifiers: 24361 AKPVrije Universiteit Brussel
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anterior Knee Pain Syndrome

Keywords

musculoskeletal ultrasound-physical tests-anterior knee pain-reliability

Outcome Measures

Primary Outcomes (1)

• Reliability and validity of physical tests and musculoskeletal ultrasound as an add-on in classifying anterior knee pain

  Measurements are taken in primary care in the Netherlands in two different healthcare settings and are taken in two ways: at first physical tests and at second using musculoskeletal ultrasound to diagnose patients with anterior knee pain.

  From April 2025 to October 2025 or until the end of the study

Study Arms (1)

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

No interventions will be applied

Eligibility Criteria

• Age: 7 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants in primary care with non-traumatic anterior knee pain

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Joannes M Hallegraeff, MSc, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joannes Marinus Hallegraeff, MSc, PhD

CONTACT

0031655955742; Joannes.Marinus.Hallegraeff@vub.be

Henk van der Pijl, MSc

CONTACT

0031654388676; henkvdpijl@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. in clinical epidemiology

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03