NCT04716608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

January 19, 2021

Last Update Submit

September 12, 2022

Conditions

Keywords

myofascial massagestretchinghome exercisesstrengtheningKOOS-Child-Questionnaire

Outcome Measures

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

    at baseline and 8 weeks after baseline

Secondary Outcomes (4)

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

    at baseline and 8 weeks after baseline

  • Change in Range of motion (ROM) of knee

    at baseline and 8 weeks after baseline

  • Change in Y Balance Test (Lower Quarter)

    at baseline and 8 weeks after baseline

  • Time of return to sport activity (in days)

    within 8 weeks after baseline

Study Arms (2)

Group 1 INT (= intervention)

ACTIVE COMPARATOR

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

Group 2 USC (= usual care)

PLACEBO COMPARATOR

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

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.

Group 1 INT (= intervention)

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

Group 2 USC (= usual care)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Osteochondrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Oliver Faude, PD Dr. med.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised controlled parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 20, 2021

Study Start

November 11, 2020

Primary Completion

July 7, 2022

Study Completion

July 7, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations