Adolescent Knee Pain (AK-Pain) Prognostic Tool

NCT ID: NCT03995771

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children and adolescents with knee pain

Children and adolescents (8-19 years old) presenting to general practice for knee pain

Questionnaire delivery

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Andreucci

Dr. Alessandro Andreucci, post-doc researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Andreucci, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Aalborg

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 32399187 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.generalpractice.aau.dk

Webpage of the Center for General Practice at Aalborg University

Other Identifiers

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AAndreucci

Identifier Type: -

Identifier Source: org_study_id

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