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

NCT05791513 | Completed

• 1 other identifier: N-20220043
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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.

  During baseline and at the 12-week and 52-week follow-ups

Secondary Outcomes (8)

• KOOS-Child Symptoms subscale

  During baseline and at the 12-week and 52-week follow-ups

• KOOS-Child Activities of daily living subscale

  During baseline and at the 12-week and 52-week follow-ups

• KOOS-Child Sport/recreation subscale

  During baseline and at the 12-week and 52-week follow-ups

• KOOS-Child Quality of Life subscale

  During baseline and at the 12-week and 52-week follow-ups

• EQ-5D-Y

  During baseline and at the 12-week and 52-week follow-ups

Other Outcomes (1)

• Anterior Knee Pain Youth (AKP-Youth)

  During baseline and at the 12-week and 52-week follow-ups

Study Arms (2)

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.

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.

Other: Usual practice

Interventions

Using the MAP-Knee Tool OTHER

Using the MAP-Knee Tool

Using the MAP-Knee Tool

Usual practice OTHER

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

Not using the MAP-Knee Tool

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (6)

Aalborg Universitetshospital

Aalborg, Denmark

Location

Amager-Hvidovre Hospital

Copenhagen, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Sportsmedicinsk Center

Frederikshavn, Denmark

Location

Næstved Sygehus

Næstved, Denmark

Location

Vejle Sygehus

Vejle, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge randomised trial

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: May 10, 2023
• Primary Completion: July 16, 2024
• Study Completion: April 26, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (6)