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CompletedNCT04716608TrOPhyUpdated Sep 13, 2022

Treatment for Osgood Schlatter Patients With a Physiotherapy Program

An interventional study of physiotherapy program and usual care treatment in Osgood-Schlatter Disease, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osgood-Schlatter Disease

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Keywords

  • myofascial massage
  • stretching
  • home exercises
  • strengthening
  • KOOS-Child-Questionnaire
03

In context

Osteochondrosis

16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.

This study's enrollment of 36 is below the median of 51 across 13 interventional studies indexed under Osteochondrosis.

Browse Osteochondrosis studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherphysiotherapy 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.

  • Otherusual care treatment

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline and 8 weeks after baseline

Secondary outcomes

  1. 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.

    Time frame: at baseline and 8 weeks after baseline

  2. 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).

    Time frame: at baseline and 8 weeks after baseline

  3. 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.

    Time frame: at baseline and 8 weeks after baseline

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

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

    Time frame: within 8 weeks after baseline

07

Study locations

1 site
  • Department of Sport, Exercise and Health, Medical Faculty University of Basel
    Basel, 4056, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Jul 2022, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2021
First posted
Jan 20, 2021
StartActual
Nov 11, 2020
Primary completionActual
Jul 7, 2022
CompletionActual
Jul 7, 2022
Last update
Sep 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04716608
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Nov 11, 2020
Primary completion
Jul 7, 2022
Completion
Jul 7, 2022
Last update
Sep 13, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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