Adolescent Knee Pain (AK-Pain) Prognostic Tool

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: Knee Pain
• Intervention / Treatment: Other: Questionnaire delivery

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

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	Other: Questionnaire delivery; 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	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	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

• Sponsor: Aalborg University
• Collaborators: TrygFonden, Denmark
• Investigators: Principal Investigator: Alessandro Andreucci, PhD, Center for General Practice at Aalborg University

Publications and helpful links

General Publications

• Andreucci A, Holden S, Bach Jensen M, Skovdal Rathleff M. The Adolescent Knee Pain (AK-Pain) prognostic tool: protocol for a prospective cohort study. F1000Res. 2019 Dec 30;8:2148. doi: 10.12688/f1000research.21740.2. eCollection 2019.

Helpful Links

• Webpage of the Center for General Practice at Aalborg University

Study record dates

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