NCT02873143

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

August 16, 2016

Last Update Submit

January 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee pain during the last week

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

    5 years

Secondary Outcomes (15)

  • Knee pain during the last 30 days

    5 years

  • Frequency of knee pain

    5 years

  • When did your knee pain resolve

    5 years

  • Pain in other regions of the body

    5 years

  • Seeking medical attention for your knee pain

    5 years

  • +10 more secondary outcomes

Study Arms (1)

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

No intervention

The APA2011 cohort

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

January 27, 2017

Record last verified: 2017-01