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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02873143
Other study ID # 2011-0020
Secondary ID
Status Completed
Phase N/A
First received August 16, 2016
Last updated January 26, 2017
Start date September 2016
Est. completion date January 2017

Study information

Verified date January 2017
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 540
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 19 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Aalborg University Copenhagen University Hospital, Denmark, Research Unit for General Practice in Aalborg, University of Southern Denmark

Outcome

Type Measure Description Time frame Safety issue
Primary Knee pain during the last week All subjects are asked if they experienced knee pain during the last week 5 years
Secondary Knee pain during the last 30 days Did you experience knee pain during the last 30 days? 5 years
Secondary Frequency of knee pain Frequency of knee pain divided into (almost daily, several times per week, weekly, monthly, rarely, never 5 years
Secondary When did your knee pain resolve 5 years
Secondary Pain in other regions of the body 5 years
Secondary Seeking medical attention for your knee pain 5 years
Secondary Previous treatments for your knee pain 5 year
Secondary Use of pain medication 5 years
Secondary Worst pain last week Measured on a numeric rating scale 5 years
Secondary Knee Injury and Osteoarthritis Outcome score 5 years
Secondary Health-related quality of life Measure with the EQ-5D-3L 5 years
Secondary The influence of knee pain on choice of activity level, mood, choice of education and professional career 5 years
Secondary Physical activity level Measured with the IPAQ 5 years
Secondary Number of sports participation per week 5 years
Secondary The effect of knee pain on sports participation 5 years
Secondary Self-reported sleep problems Assessed by asking three questions related to: trouble falling asleep, wake several times per night and trouble staying asleep. 5 years
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