Treatment for Osgood Schlatter Patients With a Physiotherapy Program

Osgood-Schlatter Disease Clinical Trial

— TrOPhy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716608
• Other study ID #: 2020-02132; ks20Neuhaus
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: July 7, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osgood-Schlatter Disease

Intervention

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.
• usual care treatment
stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks

Locations

Country	Name	City	State
Switzerland	Department of Sport, Exercise and Health, Medical Faculty University of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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