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Completed

NCT Number: NCT04716608

Treatment for Osgood Schlatter Patients With a Physiotherapy Program

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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Key information

Conditions

Osgood-Schlatter Disease Bone Diseases Musculoskeletal Diseases Osteochondrosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sport, Exercise and Health, Medical Faculty University of Basel

Basel, 4056, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. change in Knee and Osteoarthritis Outcome Score for Children (KOOS-Child-Questionnaire Score)

    Time frame: 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

  1. Change in Knee pain assessed by Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Change in Range of motion (ROM) of knee

    Time frame: 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).

  3. Change in Y Balance Test (Lower Quarter)

    Time frame: 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.

  4. Time of return to sport activity (in days)

    Time frame: within 8 weeks after baseline

    Time of return to sport activity (in days) since start of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: TrOPhy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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