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Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.

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ClinicalTrials.gov Identifier: NCT02799394
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Skovdal Rathleff, Aalborg University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osgood Schlatter Disease Other: Activity modification, exercises and gradual return to sport Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Activity modification, exercises and gradual return to sport Other: Activity modification, exercises and gradual return to sport



Primary Outcome Measures :
  1. Self-reported recovery on a 7-point Likert scale [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Self-reported recovery on a 7-point Likert scale [ Time Frame: 4 and 8 weeks + 6 and 12 months after inclusion. ]
  2. Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score" [ Time Frame: 4, 8 and 12 weeks + 6 and 12 months after inclusion. ]
  3. Isometric hip and knee extension strength assessed using a strap-mounted dynamometer [ Time Frame: 4, 8 and 12 weeks after inclusion. ]
  4. 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. ]
  5. Thigh circumference measured using tape measure. [ Time Frame: 4, 8 and 12 weeks after inclusion. ]
  6. 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. ]
  7. 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. ]
  8. Flexibility of the hamstrings and quadriceps [measured using goniometer]. [ Time Frame: 4, 8 and 12 weeks after inclusion. ]


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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799394


Locations
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Denmark
Aalborg Universitetshospital
Aalborg, The North Denmark Region, Denmark, 9000
Hvidovre-Amager Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Aalborg University

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Responsible Party: Michael Skovdal Rathleff, Senior Researcher, Aalborg University
ClinicalTrials.gov Identifier: NCT02799394    
Other Study ID Numbers: N- 20140100-1
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made publicly available no later than six months after the final publication.
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases