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

Osgood Schlatter Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799394
• Other study ID #: N- 20140100-1
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: January 27, 2018
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Osgood Schlatter Disease

Intervention

Other:
• Activity modification, exercises and gradual return to sport

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg	The North Denmark Region
Denmark	Hvidovre-Amager Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported recovery on a 7-point Likert scale		3 months
Secondary	Self-reported recovery on a 7-point Likert scale		4 and 8 weeks + 6 and 12 months after inclusion.
Secondary	Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"		4, 8 and 12 weeks + 6 and 12 months after inclusion.
Secondary	Isometric hip and knee extension strength assessed using a strap-mounted dynamometer		4, 8 and 12 weeks after inclusion.
Secondary	Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.		4, 8 and 12 weeks after inclusion.
Secondary	Thigh circumference measured using tape measure.		4, 8 and 12 weeks after inclusion.
Secondary	Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]		4, 8 and 12 weeks after inclusion.
Secondary	Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).		4, 8 and 12 weeks after inclusion.
Secondary	Flexibility of the hamstrings and quadriceps [measured using goniometer].		4, 8 and 12 weeks after inclusion.