Anterior Knee Pain SyndromeAKPNCT06904352
Reliability and Validity of Physical Tests and Musculoskeletal Ultrasound As an Add-on in Classifying Anterior Knee Pain
An observational study of Anterior Knee Pain Syndrome, run by Vrije Universiteit Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 50 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants in primary care with non-traumatic anterior knee pain
Who may be able to join
- All consecutive patients presenting clinical symptoms of AKP were screened for eligibility.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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
- Keywords
- musculoskeletal ultrasound-physical tests-anterior knee pain-reliability
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients with on-traumatic anterior knee pain in primary care physiotherapy and general practice | No interventions will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From April 2025 to October 2025 or until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joannes M Hallegraeff, Vrije Universiteit Brussel
- Investigators
- Joannes M Hallegraeff, MSc, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904352
- Sponsor's protocol ID
- 24361 AKP
- Other IDs
- Vrije Universiteit Brussel
- Acronym
- AKP
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is an initial study who focus on this topic. We first want to assess whether the data is adeqauate enough to possibly share with other researchers. We are not thinking of doing so for the time being.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Physical Tests and Musculoskeletal Ultrasound As an Add-on in Classifying Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT06904352
- Acronym / sponsor ID
- AKP / 24361 AKP
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- musculoskeletal ultrasound-physical tests-anterior knee pain-reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Apr 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients with on-traumatic anterior knee pain in primary care physiotherapy and general practice | – | –No interventions will be applied |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants in primary care with non-traumatic anterior knee pain
Key inclusion criteria (1 listed)
- All consecutive patients presenting clinical symptoms of AKP were screened for eligibility.
Key exclusion criteria (1 listed)
- 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.
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
Reliability and validity of physical tests and musculoskeletal ultrasound as an add-on in classifying anterior knee pain
Time frame: From April 2025 to October 2025 or until the end of the study
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided. This is an initial study who focus on this topic. We first want to assess whether the data is adeqauate enough to possibly share with other researchers. We are not thinking of doing so for the time being.
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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.
Joannes M Hallegraeff, MSc, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Knee Pain Syndrome, run by Vrije Universiteit Brussel.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joannes Marinus Hallegraeff, MSc, PhD (0031655955742, Joannes.Marinus.Hallegraeff@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and validity of physical tests and musculoskeletal ultrasound as an add-on in classifying anterior knee pain (time frame: From April 2025 to October 2025 or until the end of the study). 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 1 Apr 2025.