Knee Pain ChronicMAP-KneeNCT05791513
The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain
A study testing Using the MAP-Knee Tool and Usual practice in people with Knee Pain Chronic, run by Aalborg University at 6 sites in Denmark.
Trial summary
The aim of the stepped-wedge cluster randomised trial is to investigate the effectiveness of using a clinical support tool (The MAP-Knee Tool) in managing adolescents aged 10-19 years with non-traumatic knee pain compared to not using the tool. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Using the MAP-Knee Tool and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesDenmark
- Study dates
- 10 May 2023to 26 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having been referred to a hospital due to non-traumatic knee pain
- Age between 10 and 19 years
Who cannot join
- Knee pain with a traumatic origin
- Lack of ability to cooperate
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Aalborg Universitetshospital
Aalborg
Amager-Hvidovre Hospital
Copenhagen
Bispebjerg Hospital
Copenhagen
Sportsmedicinsk Center
Frederikshavn
Næstved Sygehus
Næstved
Vejle Sygehus
Vejle
About this study
Official title: The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain (The MAP-Knee Trial): a Stepped-wedge Cluster Randomised Trial
The aim of the stepped-wedge cluster randomised trial is to investigate the effectiveness of using a clinical support tool (The MAP-Knee Tool) in managing adolescents aged 10-19 years with non-traumatic knee pain compared to not using the tool. Six participating hospitals will start to use the tool within 4, 6, or 8 months after recruitment start in a randomised order. We will investigate if using the tool is superior in terms of reducing symptoms compared to not using the tool.
Read the detailed description
The trial will be designed as a stepped-wedge cluster randomised superiority trial to be conducted across 6 hospital departments across Denmark. Any orthopaedic or similar hospital department in Denmark to which adolescents suffering from non-traumatic knee pain may be referred is eligible for participation. Any medical doctor or physiotherapist employed at either of the study sites who regularly see adolescents with non-traumatic knee pain will be eligible to participate in the trial.
Before crossover occurs at the study site, the adolescents will be treated as usual which is at the discretion of the treating clinician. Based on our current research on the usual care pathway, this will be heterogenous and include advice to wait and see, imaging (most often MRI and x-ray), or a rehabilitation plan for the municipality. After crossing over to using the MAP-Knee Tool, the treating clinician will use the MAP-Knee Tool together with the adolescent. The tool was designed to support the entire consultation from diagnosing the condition (patellofemoral pain, Osgood-Schlatter, Sinding-Larsson-Johansson, growth pain, patellar tendinopathy, or iliotibial band syndrome) to deciding on future management. The MAP-Knee Tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis, and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence. After the initial prototype of the tool including all four components had been made, the investigators performed end-user testing using think-aloud sessions with adolescents suffering from non-traumatic knee pain, adolescents with no history of knee pain, and medical doctors.
- Conditions
- Knee Pain Chronic
- Being tested
- Using the MAP-Knee Tool, Usual practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the MAP-Knee ToolOther
Using the MAP-Knee Tool
Usual practiceOther
The consultation between clinician and adolescent is conducted as per usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Using the MAP-Knee Tool | Experimental | The treating clinician will use the MAP-Knee Tool together with the adolescent. The tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis(19), and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence. Receives: Other: Using the MAP-Knee Tool |
| Not using the MAP-Knee Tool | Active comparator | The treating clinician will not use the MAP-Knee Tool in the consultation and will conduct the consultation as per usual practice. Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS-Child Pain subscale
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
Measured: During baseline and at the 12-week and 52-week follow-ups
Secondary outcomes (8)
KOOS-Child Symptoms subscale
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
Measured: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Activities of daily living subscale
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
Measured: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Sport/recreation subscale
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
Measured: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Quality of Life subscale
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
Measured: During baseline and at the 12-week and 52-week follow-ups
EQ-5D-Y
Health-related quality of life will be estimated by the EQ-5D-Youth questionnaire which is an adapted version of the EQ-5D used in an adult population, yet, it still consists of the same five subscales which are mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.
Measured: During baseline and at the 12-week and 52-week follow-ups
Global Rating of Change
This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse". Participants are categorised as improved if they rate themselves as "much improved" or "improved" (category 6-7) and categorised as not improved if they rate themselves from "slightly improved" to "much worse" (category 1-5).
Measured: At the 12-week and 52-week follow-ups
International Physical Activity Questionnaire short version (IPAQ).
The IPAQ is the most used questionnaire for measuring physical activity and consists of 9 items that provide information on the time spent performing vigorous and moderate activities, the time spent walking, and time spent sedentary during the past week. The IPAQ gives an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting.
Measured: During baseline and at the 12-week and 52-week follow-ups
Sports participation
Change in sports participation will be explored using a questionnaire in which participants are asked about whether they have participated in leisure sports activities, type of sports activities and weekly frequency.
Measured: During baseline and at the 12-week and 52-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start10 May 2023
- Primary completion16 Jul 2024
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge randomised trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Skovdal Rathleff, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791513
- Sponsor's protocol ID
- N-20220043
- Acronym
- MAP-Knee
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain (The MAP-Knee Trial): a Stepped-wedge Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT05791513
- Acronym / sponsor ID
- MAP-Knee / N-20220043
- Conditions
- Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 26 Apr 2025 (actual)
- First posted
- 30 Mar 2023 (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.
The aim of the stepped-wedge cluster randomised trial is to investigate the effectiveness of using a clinical support tool (The MAP-Knee Tool) in managing adolescents aged 10-19 years with non-traumatic knee pain compared to not using the tool. Six participating hospitals will start to use the tool within 4, 6, or 8 months after recruitment start in a randomised order. We will investigate if using the tool is superior in terms of reducing symptoms compared to not using the tool.
Detailed description
The trial will be designed as a stepped-wedge cluster randomised superiority trial to be conducted across 6 hospital departments across Denmark. Any orthopaedic or similar hospital department in Denmark to which adolescents suffering from non-traumatic knee pain may be referred is eligible for participation. Any medical doctor or physiotherapist employed at either of the study sites who regularly see adolescents with non-traumatic knee pain will be eligible to participate in the trial.
Before crossover occurs at the study site, the adolescents will be treated as usual which is at the discretion of the treating clinician. Based on our current research on the usual care pathway, this will be heterogenous and include advice to wait and see, imaging (most often MRI and x-ray), or a rehabilitation plan for the municipality. After crossing over to using the MAP-Knee Tool, the treating clinician will use the MAP-Knee Tool together with the adolescent. The tool was designed to support the entire consultation from diagnosing the condition (patellofemoral pain, Osgood-Schlatter, Sinding-Larsson-Johansson, growth pain, patellar tendinopathy, or iliotibial band syndrome) to deciding on future management. The MAP-Knee Tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis, and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence. After the initial prototype of the tool including all four components had been made, the investigators performed end-user testing using think-aloud sessions with adolescents suffering from non-traumatic knee pain, adolescents with no history of knee pain, and medical doctors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge randomised trial
| Arm | Type | Receives |
|---|---|---|
| Using the MAP-Knee Tool | Experimental | Other: Using the MAP-Knee ToolThe treating clinician will use the MAP-Knee Tool together with the adolescent. The tool includes four separate components: 1) a tool for diagnosing the most common types of non-traumatic knee pain (SMILE), 2) credible explanations of the aetiology and pathogenesis specific to the diagnosis based on multiple methods with an iterative design, 3) a presentation of prognostic factors based on an individual participant data meta-analysis(19), and 4) an option grid that presents the users of the tool with pros and cons of commonly used management options based on a systematic literature search of systematic and narrative reviews within non-traumatic adolescent knee pain. An overarching focus of all components was to support shared decision-making and base decisions on all three pillars of evidence-based medicine: patient values, clinical expertise, and relevant research. Therefore, the tool should not provide the users with definitive answers simply based on available evidence. |
| Not using the MAP-Knee Tool | Active comparator | Other: Usual practiceThe treating clinician will not use the MAP-Knee Tool in the consultation and will conduct the consultation as per usual practice. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Having been referred to a hospital due to non-traumatic knee pain
- Age between 10 and 19 years
Key exclusion criteria (2 listed)
- Knee pain with a traumatic origin
- Lack of ability to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using the MAP-Knee ToolUsing the MAP-Knee Tool | Other | Using the MAP-Knee Tool |
| Usual practiceThe consultation between clinician and adolescent is conducted as per usual practice. | Other | Not using the MAP-Knee Tool |
Primary outcome
KOOS-Child Pain subscale
Time frame: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child consists of 39 items divided into five subscales (Pain, Symptoms, Activities of Daily Living, Sport/Recreation, and Quality of Life) that each range from 0 to 100 with 100 being optimum. This questionnaire has been found to have good psychometric properties and is recommended for children and adolescents suffering from knee disorders.
8 secondary outcomes
KOOS-Child Symptoms subscale
Time frame: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Activities of daily living subscale
Time frame: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Sport/recreation subscale
Time frame: During baseline and at the 12-week and 52-week follow-ups
KOOS-Child Quality of Life subscale
Time frame: During baseline and at the 12-week and 52-week follow-ups
EQ-5D-Y
Time frame: During baseline and at the 12-week and 52-week follow-ups
Global Rating of Change
Time frame: At the 12-week and 52-week follow-ups
International Physical Activity Questionnaire short version (IPAQ).
Time frame: During baseline and at the 12-week and 52-week follow-ups
Sports participation
Time frame: During baseline and at the 12-week and 52-week follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the MAP-Knee Tool and Usual practice in people with Knee Pain Chronic, run by Aalborg University at 6 sites in Denmark.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS-Child Pain subscale (time frame: During baseline and at the 12-week and 52-week follow-ups). 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 4 Jun 2025.