Treatment for Osgood Schlatter Patients With a Physiotherapy Program

NCT04716608 — Not applicable, Completed, 36 participants, University Hospital, Basel, Switzerland

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

Registry	NCT04716608, acronym TrOPhy
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	36 (Actual)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Osgood-Schlatter Disease
Interventions	physiotherapy program, usual care treatment (Other)
Dates	start 2020-11-11, primary completion 2022-07-07, completion 2022-07-07, first posted 2021-01-20, last updated 2022-09-13
Locations	1 site in Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1 INT (= intervention)	Active comparator	Other: physiotherapy program	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)
Group 2 USC (= usual care)	Placebo comparator	Other: usual care treatment	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)

physiotherapy program (Other): 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 (Other): stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks

+Outcome measures

Primary outcomes

change in Knee and Osteoarthritis Outcome Score for Children (KOOS-Child-Questionnaire Score) [at baseline and 8 weeks after baseline]: 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

Secondary outcomes

Change in Knee pain assessed by Visual Analogue Scale (VAS) [at baseline and 8 weeks after baseline]: 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.
Change in Range of motion (ROM) of knee [at baseline and 8 weeks after baseline]: 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).
Change in Y Balance Test (Lower Quarter) [at baseline and 8 weeks after baseline]: 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.
Time of return to sport activity (in days) [within 8 weeks after baseline]: Time of return to sport activity (in days) since start of treatment

+Eligibility

Sex: All, ages: 10 Years to 17 Years

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)

+Locations (1)

Facility	City	Country	Status
Department of Sport, Exercise and Health, Medical Faculty University of Basel	Basel	Switzerland

+Investigators

Oliver Faude, PD Dr. med., Principal investigator, Department of Sport, Exercise and Health, Medical Faculty University of Basel