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

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

      • Hvidovre, Denmark, 2650
        • Hvidovre-Amager Hospital
    • The North Denmark Region
      • Aalborg, The North Denmark Region, Denmark, 9000
        • Aalborg Universitetshospital

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
EXPERIMENTAL: Activity modification, exercises and gradual return to sport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported recovery on a 7-point Likert scale
Time Frame: 3 months
3 months

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.
4 and 8 weeks + 6 and 12 months after inclusion.
Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"
Time Frame: 4, 8 and 12 weeks + 6 and 12 months after inclusion.
4, 8 and 12 weeks + 6 and 12 months after inclusion.
Isometric hip and knee extension strength assessed using a strap-mounted dynamometer
Time Frame: 4, 8 and 12 weeks after inclusion.
4, 8 and 12 weeks after inclusion.
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.
4, 8 and 12 weeks after inclusion.
Thigh circumference measured using tape measure.
Time Frame: 4, 8 and 12 weeks after inclusion.
4, 8 and 12 weeks after inclusion.
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.
4, 8 and 12 weeks after inclusion.
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.
4, 8 and 12 weeks after inclusion.
Flexibility of the hamstrings and quadriceps [measured using goniometer].
Time Frame: 4, 8 and 12 weeks after inclusion.
4, 8 and 12 weeks after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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