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CompletedNCT02799394Updated Jan 30, 2018

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

An interventional study of Activity modification, exercises and gradual return to sport in Osgood Schlatter Disease, sponsored by Aalborg University. Completed at 2 sites in Denmark. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Aalborg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
10 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osgood Schlatter Disease

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03

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Activity modification, exercises and gradual return to sport

    Other: Activity modification, exercises and gradual return to sport

Interventions

  • OtherActivity modification, exercises and gradual return to sport
05

What researchers measure

Primary outcomes

  1. Self-reported recovery on a 7-point Likert scale

    Time frame: 3 months

Secondary outcomes

  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.

06

Study locations

2 sites
  • Aalborg Universitetshospital
    Aalborg, The North Denmark Region 9000, Denmark
  • Hvidovre-Amager Hospital
    Hvidovre, 2650, Denmark
07

References and documents

Publications

  • Rathleff MS, Winiarski L, Krommes K, Graven-Nielsen T, Holmich P, Olesen JL, Holden S, Thorborg K. Activity Modification and Knee Strengthening for Osgood-Schlatter Disease: A Prospective Cohort Study. Orthop J Sports Med. 2020 Apr 6;8(4):2325967120911106. doi: 10.1177/2325967120911106. eCollection 2020 Apr. PubMed 32284945 ↗

Individual participant data

Plan to share: Yes — Data will be made publicly available no later than six months after the final publication.

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Registry details

Key details

Study ID
NCT02799394
Lead sponsor
Aalborg University
Responsible party
Michael Skovdal Rathleff (Senior Researcher, Aalborg University) — Principal investigator
First posted
Jun 14, 2016
Start date
Jun 2016
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Jan 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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