- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799394
Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
January 27, 2018 updated by: Michael Skovdal Rathleff, Aalborg University
The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease.
The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months.
Secondary endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project.
The adolescents will be recruited from primary schools, general practitioners and through online advertising on Facebook.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre-Amager Hospital
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The North Denmark Region
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Aalborg, The North Denmark Region, Denmark, 9000
- Aalborg Universitetshospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 10-14 years of age
- Pain at tuberositas patellae during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
- Pain during palpation of tuberositas patellae
- Knee pain for 6 weeks or more
Exclusion Criteria:
- Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
- Previous surgery
- Pain from the hip or back that interferes with activities of daily living.
- Habitual patella luxations
- Clinical suspicion of meniscal lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Activity modification, exercises and gradual return to sport
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Self-reported recovery on a 7-point Likert scale
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported recovery on a 7-point Likert scale
Time Frame: 4 and 8 weeks + 6 and 12 months after inclusion.
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4 and 8 weeks + 6 and 12 months after inclusion.
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Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"
Time Frame: 4, 8 and 12 weeks + 6 and 12 months after inclusion.
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4, 8 and 12 weeks + 6 and 12 months after inclusion.
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Isometric hip and knee extension strength assessed using a strap-mounted dynamometer
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Thigh circumference measured using tape measure.
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Flexibility of the hamstrings and quadriceps [measured using goniometer].
Time Frame: 4, 8 and 12 weeks after inclusion.
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4, 8 and 12 weeks after inclusion.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
December 1, 2017
Study Completion (ACTUAL)
December 1, 2017
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 10, 2016
First Posted (ESTIMATE)
June 14, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 27, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N- 20140100-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be made publicly available no later than six months after the final publication.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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