Adolescent Knee Pain (AK-Pain) Prognostic Tool

February 19, 2023 updated by: Alessandro Andreucci, Aalborg University

The overall aim of this study is to develop and test a prognostic tool for knee pain in children and adolescents to be used in general practice.

By using the tool, general practitioners will be able to allocate the patient to a category of risk (e.g. low/medium/high) of recurrent or persistent knee pain at 3 months and 6 months, and to subsequently provide a treatment that is specific to the category of risk of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One in three children and adolescents experience knee pain, and one in two will have a poor long-term prognosis with low quality of life and impaired physical activity levels.

Every year 119 - 200 children and adolescents per 10,000 registered patients consult their general practitioner for knee pain, and a variety of treatments are delivered, despite similar symptoms and patients' characteristics. However, the proportion of children and adolescents with a poor prognosis is high, which suggests that there is an urgent need to support the general practitioners in identifying those at high risk of a poor outcome early on, in order to better allocate resources.

This project will develop a user-friendly prognostic tool to support general practitioners' management of children and adolescents' knee pain.

Clinically relevant prognostic factors for child and adolescent knee pain were identified using systematic reviews and meta-analysis of individual participant data. Following feedback from general practitioners and children and adolescents on the content and understanding, the tool was piloted and implemented in general practice.

A cohort of approximately 300 children and adolescents will be recruited from general practices and followed-up for up to 6 months (the baseline starting date is July 2019 and the follow-up will end in July 2020) Clinically meaningful risk groups (e.g. low/medium/high) for the recurrence and persistence of knee pain (at 3- and 6-months) will be identified.

This tool will allow general practitioners to provide children and adolescents an optimal stratified care, by matching treatments to patients' prognostic profile.

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alessandro Andreucci, PhD
  • Phone Number: +45 50225426
  • Email: aa@dcm.aau.dk

Study Contact Backup

Study Locations

      • Aalborg, Denmark, 9000
        • Aalborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adolescents (aged 8-19 years old) who consult their general practitioner because of their knee pain

Description

Inclusion Criteria:

  • Children and adolescents (aged 8-19 years old) who consult their general practitioner because of their knee pain (of both traumatic and non-traumatic origin) during a period of recruitment of 6 months (starting in July 2019)

Exclusion Criteria:

  • Age below 8 years old or over 19 years old
  • Consultation for musculoskeletal pain only in a body region different from the knee
  • Pain originated by different conditions (e.g. cancer, infections)
  • Child is vulnerable (e.g. he/she has experienced a recent trauma and the distress may have an impact on the self-report making it not valid)
  • Inability to take part to the study because of inability to understand or comply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children and adolescents with knee pain
Children and adolescents (8-19 years old) presenting to general practice for knee pain
A questionnaire including questions regarding prognostic factors for knee pain will be delivered to children and adolescents (8-19 years old) presenting to general practice with knee pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence/persistence of activity-limiting knee pain (i.e. yes/no pain that is limiting activities in the same knee) at 3-month follow-up
Time Frame: 3-month follow-up
Activity-limiting knee pain: pain that is limiting activities in the same knee. Participants will also be asked about continuity of their knee pain (i.e. "how long have you been free of knee pain?"), to enable the distinction between recurrence (on/off knee pain episodes between baseline and follow-up) and persistence (continuous knee pain from baseline to follow-up) of knee pain
3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence/persistence of activity-limiting knee pain (i.e. yes/no pain that is limiting activities in the same knee) at 6-month follow-up
Time Frame: 6-month follow-up
Activity-limiting knee pain: pain that is limiting activities in the same knee. Participants will also be asked about continuity of their knee pain (i.e. "how long have you been free of knee pain?"), to enable the distinction between recurrence (on/off knee pain episodes between baseline and follow-up) and persistence (continuous knee pain from baseline to follow-up) of knee pain
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Alessandro Andreucci, PhD, Center for General Practice at Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 15, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AAndreucci

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A procedure is being developed for making data available to interested investigators.

Investigators interested in using the data will have to apply through a data request procedure.

Data access requests will be reviewed by a panel composed by the researchers participating to the project.

Upon acceptance of the data request, a data access agreement will have to be signed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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