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Completed

NCT Number: NCT05791513

The Effectiveness of Using a Clinical Support Tool in Managing Adolescents With Non-Traumatic Knee Pain

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.

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Key information

Conditions

Knee Pain Chronic

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having been referred to a hospital due to non-traumatic knee pain
  • Age between 10 and 19 years

Exclusion criteria

  • Knee pain with a traumatic origin
  • Lack of ability to cooperate

Treatment and study plan

Using the MAP-Knee Tool

Other

Using the MAP-Knee Tool

Usual practice

Other

The consultation between clinician and adolescent is conducted as per usual practice.

Primary outcomes

  1. 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.

Secondary outcomes

  1. KOOS-Child Symptoms 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.

  2. KOOS-Child Activities of daily living 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.

  3. KOOS-Child Sport/recreation 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.

  4. KOOS-Child Quality of Life 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.

  5. EQ-5D-Y

    Time frame: During baseline and at the 12-week and 52-week follow-ups

    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.

  6. Global Rating of Change

    Time frame: At the 12-week and 52-week follow-ups

    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).

  7. International Physical Activity Questionnaire short version (IPAQ).

    Time frame: During baseline and at the 12-week and 52-week follow-ups

    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.

  8. Sports participation

    Time frame: During baseline and at the 12-week and 52-week follow-ups

    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.

Other outcomes

  1. Anterior Knee Pain Youth (AKP-Youth)

    Time frame: During baseline and at the 12-week and 52-week follow-ups

    We will use our newly developed questionnaire as a secondary measure of condition severity. The AKP-Youth contains 23 items that are divided into four overarching domains of impact: symptoms, limitations in physical activity, limitations in social activities, and emotional impact of pain.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study 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

Acronym: MAP-Knee

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 30, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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