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

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ClinicalTrials.gov Identifier: NCT04716608
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Osgood-Schlatter Disease Other: physiotherapy program Other: usual care treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled parallel groups
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Osgood Schlatter Patients With a Physiotherapy Program "TrOPhy-Study"
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716608


Contacts
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Contact: Oliver Faude, PD Dr. med. +41 61 207 47 35 oliver.faude@unibas.ch
Contact: Cornelia Neuhaus +41 61 704 25 28 cornelia.neuhaus@ukbb.ch

Locations
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Switzerland
Department of Sport, Exercise and Health, Medical Faculty University of Basel Recruiting
Basel, Switzerland, 4056
Contact: Oliver Faude, PD Dr. med.    +41 61 207 47 35    oliver.faude@unibas.ch   
Contact: Cornelia Neuhaus, MPTSc    +41 61 704 25 28    cornelia.neuhaus@ukbb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Oliver Faude, PD Dr. med. Department of Sport, Exercise and Health, Medical Faculty University of Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04716608    
Other Study ID Numbers: 2020-02132; ks20Neuhaus
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
myofascial massage
stretching
home exercises
strengthening
KOOS-Child-Questionnaire
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases