Knee PainNCT03995771
Adolescent Knee Pain (AK-Pain) Prognostic Tool
An observational study of Knee Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 19 years
- Conditions the study is for
- Knee Pain
- What is being tested?
- Questionnaire delivery
- How many people
- 131 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2019to 1 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 19 years
- All sexes
- Child, Adult
Study population: Children and adolescents (aged 8-19 years old) who consult their general practitioner because of their knee pain
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Knee Pain
- Being tested
- Questionnaire delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire deliveryOther
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
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents with knee pain | Children and adolescents (8-19 years old) presenting to general practice for knee pain Receives: Other: Questionnaire delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-month follow-up
Secondary outcomes (1)
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
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Alessandro Andreucci, Aalborg University
- Investigators
- Alessandro Andreucci, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995771
- Sponsor's protocol ID
- AAndreucci
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 32399187
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Knee Pain (AK-Pain) Prognostic Tool
- ClinicalTrials.gov ID
- NCT03995771
- Acronym / sponsor ID
- AAndreucci
- Conditions
- Knee Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with knee pain | – | Other: Questionnaire deliveryChildren and adolescents (8-19 years old) presenting to general practice for knee pain |
Who may qualify
- Ages
- 8 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents (aged 8-19 years old) who consult their general practitioner because of their knee pain
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire deliveryA 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 | Other | Children and adolescents with knee pain |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 32399187Andreucci 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.
- Webpage of the Center for General Practice at Aalborg UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Andreucci, PhD principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03995771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.