Patellofemoral Pain SyndromeNCT02873143
5 Year Follow-up of Adolescents With Knee Pain
An observational study of Patellofemoral Pain Syndrome and Knee Pain, run by Aalborg University.
Trial summary
The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared with other types of knee pain is unknown. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Knee Pain
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2017
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: In September 2011, students at 4 upper secondary schools in Aalborg were invited to answer an online questionnaire and to be part of the APA2011 cohort. From 2846 potential responders, 2200 adolescents responded to the questionnaire, corresponding to a response rate of 77%. A total of 504 adolescents indicating knee pain at least monthly were successfully contacted (a response rate of 83% of those who reported their telephone numbers) and were asked standardized questions on the telephone. This forms the cohort of 504 adolescents with knee pain. In addition a random selected group of adolescents without knee pain in 2011 will be contacted and asked the same questions as those with knee pain.
Who may be able to join
None listed.
Who cannot join
- concomitant injury or pain from the hip, lumbar spine, or other knee structures
- self-reported patellofemoral instability
- knee joint effusion.
About this study
Official title: 5 Year Follow-up of Adolescents With Knee Pain - a Prospective Cohort Study of 504 Adolescents
The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared with other types of knee pain is unknown.
In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, will be contacted again to gain insights into their prognosis.
- Conditions
- Patellofemoral Pain Syndrome, Knee Pain
- Being tested
- No intervention
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The APA2011 cohort | In September 2011, students at 4 upper secondary schools in Aalborg were invited to answer an online questionnaire and to be part of the APA2011 cohort. From 2846 potential responders, 2200 adolescents responded to the questionnaire, corresponding to a response rate of 77%. A total of 504 adolescents indicating knee pain at least monthly were successfully contacted (a response rate of 83% of those who reported their telephone numbers) and were asked standardized questions on the telephone. This forms the cohort of 504 adolescents with knee pain. In addition a random selected group of adolescents without knee pain in 2011 will be contacted and asked the same questions as those with knee pain. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain during the last week
All subjects are asked if they experienced knee pain during the last week
Measured: 5 years
Secondary outcomes (15)
Knee pain during the last 30 days
Did you experience knee pain during the last 30 days?
Measured: 5 years
Frequency of knee pain
Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never
Measured: 5 years
When did your knee pain resolve
Measured: 5 years
Pain in other regions of the body
Measured: 5 years
Seeking medical attention for your knee pain
Measured: 5 years
Previous treatments for your knee pain
Measured: 5 year
Use of pain medication
Measured: 5 years
Worst pain last week
Measured on a numeric rating scale
Measured: 5 years
Knee Injury and Osteoarthritis Outcome score
Measured: 5 years
Health-related quality of life
Measure with the EQ-5D-3L
Measured: 5 years
The influence of knee pain on choice of activity level, mood, choice of education and professional career
Measured: 5 years
Physical activity level
Measured with the IPAQ
Measured: 5 years
Number of sports participation per week
Measured: 5 years
The effect of knee pain on sports participation
Measured: 5 years
Self-reported sleep problems
Assessed by asking three questions related to: trouble falling asleep, wake several times per night and trouble staying asleep.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionJan 2017
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 Patellofemoral Pain SyndromeStudies 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
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice in Aalborg, University of Southern Denmark, Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Michael Skovdal Rathleff, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873143
- Sponsor's protocol ID
- 2011-0020
- Status last verified
- Jan 2017
- First submitted
- 16 Aug 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rathleff MS, Holden S, Straszek CL, Olesen JL, Jensen MB, Roos EM. Five-year prognosis and impact of adolescent knee pain: a prospective population-based cohort study of 504 adolescents in Denmark. BMJ Open. 2019 May 28;9(5):e024113. doi: 10.1136/bmjopen-2018-024113.
PubMed 31142518
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Year Follow-up of Adolescents With Knee Pain - a Prospective Cohort Study of 504 Adolescents
- ClinicalTrials.gov ID
- NCT02873143
- Acronym / sponsor ID
- 2011-0020
- Conditions
- Patellofemoral Pain Syndrome, Knee Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Research Unit for General Practice in Aalborg, University of Southern Denmark, Copenhagen University Hospital, Denmark
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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 prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared with other types of knee pain is unknown.
In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, will be contacted again to gain insights into their prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The APA2011 cohort | – | Other: No interventionIn September 2011, students at 4 upper secondary schools in Aalborg were invited to answer an online questionnaire and to be part of the APA2011 cohort. From 2846 potential responders, 2200 adolescents responded to the questionnaire, corresponding to a response rate of 77%. A total of 504 adolescents indicating knee pain at least monthly were successfully contacted (a response rate of 83% of those who reported their telephone numbers) and were asked standardized questions on the telephone. This forms the cohort of 504 adolescents with knee pain. In addition a random selected group of adolescents without knee pain in 2011 will be contacted and asked the same questions as those with knee pain. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In September 2011, students at 4 upper secondary schools in Aalborg were invited to answer an online questionnaire and to be part of the APA2011 cohort. From 2846 potential responders, 2200 adolescents responded to the questionnaire, corresponding to a response rate of 77%. A total of 504 adolescents indicating knee pain at least monthly were successfully contacted (a response rate of 83% of those who reported their telephone numbers) and were asked standardized questions on the telephone. This forms the cohort of 504 adolescents with knee pain. In addition a random selected group of adolescents without knee pain in 2011 will be contacted and asked the same questions as those with knee pain.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- concomitant injury or pain from the hip, lumbar spine, or other knee structures
- self-reported patellofemoral instability
- knee joint effusion.
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 |
|---|---|---|
| No interventionNo intervention | Other | The APA2011 cohort |
Primary outcome
Knee pain during the last week
Time frame: 5 years
All subjects are asked if they experienced knee pain during the last week
15 secondary outcomes
Knee pain during the last 30 days
Time frame: 5 years
Frequency of knee pain
Time frame: 5 years
When did your knee pain resolve
Time frame: 5 years
Pain in other regions of the body
Time frame: 5 years
Seeking medical attention for your knee pain
Time frame: 5 years
Previous treatments for your knee pain
Time frame: 5 year
Use of pain medication
Time frame: 5 years
Worst pain last week
Time frame: 5 years
Knee Injury and Osteoarthritis Outcome score
Time frame: 5 years
Health-related quality of life
Time frame: 5 years
The influence of knee pain on choice of activity level, mood, choice of education and professional career
Time frame: 5 years
Physical activity level
Time frame: 5 years
Number of sports participation per week
Time frame: 5 years
The effect of knee pain on sports participation
Time frame: 5 years
Self-reported sleep problems
Time frame: 5 years
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 27 Jan 2017.
- Derived from this study: PubMed 31142518Rathleff MS, Holden S, Straszek CL, Olesen JL, Jensen MB, Roos EM. Five-year prognosis and impact of adolescent knee pain: a prospective population-based cohort study of 504 adolescents in Denmark. BMJ Open. 2019 May 28;9(5):e024113. doi: 10.1136/bmjopen-2018-024113.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome and Knee Pain, run by Aalborg University.
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 0 inclusion and 3 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Knee pain during the last week (time frame: 5 years). 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 NCT02873143, 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 27 Jan 2017.