Treatment for Osgood Schlatter Patients With a Physiotherapy Program (TrOPhy)

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

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.

Study Overview

• Status: Completed
• Conditions: Osgood-Schlatter Disease
• Intervention / Treatment: Other: physiotherapy program; Other: usual care treatment

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Department of Sport, Exercise and Health, Medical Faculty University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 INT (= intervention); 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; 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.
Placebo Comparator: Group 2 USC (= usual care); 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; stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Oliver Faude, PD Dr. med., Department of Sport, Exercise and Health, Medical Faculty University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: stretching; myofascial massage; home exercises; strengthening; KOOS-Child-Questionnaire
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteochondrosis
• Other Study ID Numbers: 2020-02132; ks20Neuhaus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No