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CompletedNCT02873143Updated Jan 27, 2017

5 Year Follow-up of Adolescents With Knee Pain

An observational study in Patellofemoral Pain Syndrome and Knee Pain, sponsored by Aalborg University. Completed. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-27.

Sponsored by Aalborg University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
540
Ages
15 Years to 19 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Patellofemoral Pain Syndrome
  • Knee Pain
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In context

Patellofemoral Pain Syndrome

295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.

This study's enrollment of 540 is above the median of 43 across 48 observational studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Eligibility criteria

From the 504, 153 were diagnosed with PFP, the criteria for which included:

  • insidious onset of anterior knee or retropatellar pain for longer than 6 weeks that was provoked by at least 2 of the following: prolonged sitting or kneeling, squatting, running, hopping, or stair climbing; tenderness on palpation of the patella; pain when stepping down; or double-leg squatting.

Exclusion criteria were:

  • concomitant injury or pain from the hip, lumbar spine, or other knee structures
  • self-reported patellofemoral instability
  • knee joint effusion.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
540 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Knee pain during the last week

    All subjects are asked if they experienced knee pain during the last week

    Time frame: 5 years

Secondary outcomes

  1. Knee pain during the last 30 days

    Did you experience knee pain during the last 30 days?

    Time frame: 5 years

  2. Frequency of knee pain

    Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never

    Time frame: 5 years

  3. When did your knee pain resolve

    Time frame: 5 years

  4. Pain in other regions of the body

    Time frame: 5 years

  5. Seeking medical attention for your knee pain

    Time frame: 5 years

  6. Previous treatments for your knee pain

    Time frame: 5 year

  7. Use of pain medication

    Time frame: 5 years

  8. Worst pain last week

    Measured on a numeric rating scale

    Time frame: 5 years

  9. Knee Injury and Osteoarthritis Outcome score

    Time frame: 5 years

  10. Health-related quality of life

    Measure with the EQ-5D-3L

    Time frame: 5 years

  11. The influence of knee pain on choice of activity level, mood, choice of education and professional career

    Time frame: 5 years

  12. Physical activity level

    Measured with the IPAQ

    Time frame: 5 years

  13. Number of sports participation per week

    Time frame: 5 years

  14. The effect of knee pain on sports participation

    Time frame: 5 years

  15. Self-reported sleep problems

    Assessed by asking three questions related to: trouble falling asleep, wake several times per night and trouble staying asleep.

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02873143
Lead sponsor
Aalborg University
Collaborators
Research Unit for General Practice in Aalborg, University of Southern Denmark, Copenhagen University Hospital, Denmark
Responsible party
Michael Skovdal Rathleff (Senior researcher, Aalborg University) — Principal investigator
First posted
Aug 19, 2016
Start date
Sep 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
Jan 27, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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