Clinical trial NCT02799394: Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
Official title: Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osgood Schlatter Disease
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 51
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Self-reported recovery on a 7-point Likert scale
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported recovery on a 7-point Likert scale
timeFrame: 4 and 8 weeks + 6 and 12 months after inclusion.
measure: Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"
timeFrame: 4, 8 and 12 weeks + 6 and 12 months after inclusion.
measure: Isometric hip and knee extension strength assessed using a strap-mounted dynamometer
timeFrame: 4, 8 and 12 weeks after inclusion.
measure: Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.
timeFrame: 4, 8 and 12 weeks after inclusion.
measure: Thigh circumference measured using tape measure.
timeFrame: 4, 8 and 12 weeks after inclusion.
measure: Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]
timeFrame: 4, 8 and 12 weeks after inclusion.
measure: Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).
timeFrame: 4, 8 and 12 weeks after inclusion.
measure: Flexibility of the hamstrings and quadriceps [measured using goniometer].
timeFrame: 4, 8 and 12 weeks after inclusion.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: The North Denmark Region
city: Hvidovre
country: Denmark
facility: Hvidovre-Amager Hospital
Study officials:
References:
citation: 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.