Treatment for Osgood Schlatter Patients With a Physiotherapy Program

Study Overview
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Brief Summary
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This study is to compare the effect of a physiotherapy program to usual care treatment in patients with Osgood Schlatter disease (OSD). Patients will be randomly assigned into two groups. Group 1 will receive the physiotherapy program with myofascial massage, while group 2 (usual care group USC) will receive usual care treatment.

Official Title
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Treatment for Osgood Schlatter Patients With a Physiotherapy Program TrOPhy-Study

Conditions
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Osgood-Schlatter Disease

Intervention / Treatment
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* Other: physiotherapy program
* Other: usual care treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uni- or bilateral OSD ability to follow instructions sufficient knowledge of German availability: can participate in two exercise sessions per week for a period of 8 weeks Exclusion Criteria: any history of knee surgery medication intake affecting the knee unstable fractures neurological disorders systematic diseases already in physiotherapeutic treatment because of the knee not possible to do any physiotherapy sessions at the Universitäts-Kinderspital Basel (UKBB)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled parallel groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 INT (= intervention)<br>physiotherapy program with Myofascial Release Massage (quadriceps) Foam Rolling lower extremity Knee Isometrics in knee extension (sitting position) Dynamic and static stretching (quadriceps) in half knee position Core Stability (planks) Strengthening (calf raises, good morning,squats, squat jump) Balance (single leg stance) | Other: physiotherapy program<br>* physiotherapy program with Myofascial Release Massage, stretching, strengthening. 2 sessions per week (duration 30 minutes per session) for 8 weeks, supervised by a physiotherapist; complemented by a home training program.<br>|
| Placebo Comparator: Group 2 USC (= usual care)<br>usual care treatment with Core Stability (prone plank) Strengthening: (Hip extension, abduction; Calf raises) Stretching (M. rectus femoris (static) in standing position; Hamstring in sitting position) Balance (single leg stand) | Other: usual care treatment<br>* stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Knee and Osteoarthritis Outcome Score for Children (KOOS-Child-Questionnaire Score) | KOOS-Child is a patient-reported outcome measure employing five-item Likert scales. KOOS-Child covers 5 dimensions (subscales): Pain, Symptoms (titled Knee problems in the KOOS-Child), Difficulty during daily activities (ADL), Function in sport and play (Sports/Play) and knee-related Quality of Life (QOL). 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems | at baseline and 8 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee pain assessed by Visual Analogue Scale (VAS) | The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, 10 cm in length, with the left side signifying no pain and the right side signifying the worst pain ever. | at baseline and 8 weeks after baseline | 
| Change in Range of motion (ROM) of knee | Range of motion is typically measured using a goniometer. Normal ROM at the knee is considered to be 0 degrees of extension (completely straight knee joint) to 135 degrees of flexion (fully bent knee joint). | at baseline and 8 weeks after baseline | 
| Change in Y Balance Test (Lower Quarter) | The Y-Balance Test is a dynamic test performed in a single-leg stance that requires strength, flexibility, core control and proprioception. The goal of this test is to maintain single-leg balance on one leg while reaching as far as possible with the contralateral leg in three different directions. The three movement directions are anterior, posteromedial and posterolateral, performed on each leg. Each test is repeated three times, and the maximum reach in each direction is recorded. | at baseline and 8 weeks after baseline | 
| Time of return to sport activity (in days) | Time of return to sport activity (in days) since start of treatment | within 8 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myofascial massage, stretching, home exercises, strengthening, KOOS-Child-Questionnaire