Osgood-Schlatter DiseaseTrOPhyNCT04716608
Treatment for Osgood Schlatter Patients With a Physiotherapy Program
A study testing physiotherapy program in people with Osgood-Schlatter Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Osgood-Schlatter Disease
- What is being tested?
- physiotherapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2020to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Sport, Exercise and Health, Medical Faculty University of Basel
Basel, 4056
About this study
Official title: Treatment for Osgood Schlatter Patients With a Physiotherapy Program "TrOPhy-Study"
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.
- Conditions
- Osgood-Schlatter Disease
- Being tested
- physiotherapy program, usual care treatment
- Keywords
- myofascial massage, stretching, home exercises, strengthening, KOOS-Child-Questionnaire
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy programOther
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 treatmentOther
stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: usual care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline and 8 weeks after baseline
Secondary outcomes (4)
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.
Measured: at baseline and 8 weeks after baseline
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).
Measured: at baseline and 8 weeks after baseline
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.
Measured: at baseline and 8 weeks after baseline
Time of return to sport activity (in days)
Time of return to sport activity (in days) since start of treatment
Measured: within 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start11 Nov 2020
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osgood-Schlatter DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Faude, PD Dr. med., Principal investigator, Department of Sport, Exercise and Health, Medical Faculty University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716608
- Sponsor's protocol ID
- 2020-02132; ks20Neuhaus
- Acronym
- TrOPhy
- Status last verified
- Sep 2022
- First submitted
- 19 Jan 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Osgood Schlatter Patients With a Physiotherapy Program "TrOPhy-Study"
- ClinicalTrials.gov ID
- NCT04716608
- Acronym / sponsor ID
- TrOPhy / 2020-02132; ks20Neuhaus
- Conditions
- Osgood-Schlatter Disease
- Keywords
- myofascial massage, stretching, home exercises, strengthening, KOOS-Child-Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled parallel groups
| Arm | Type | Receives |
|---|---|---|
| Group 1 INT (= intervention) | Active comparator | Other: physiotherapy programphysiotherapy 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 treatmentusual 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) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- any history of knee surgery
- medication intake affecting the knee
- unstable fractures
- neurological disorders
- systematic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapy programphysiotherapy 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. | Other | Group 1 INT (= intervention) |
| usual care treatmentstretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks | Other | Group 2 USC (= usual care) |
Primary outcome
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
4 secondary outcomes
Change in Knee pain assessed by Visual Analogue Scale (VAS)
Time frame: at baseline and 8 weeks after baseline
Change in Range of motion (ROM) of knee
Time frame: at baseline and 8 weeks after baseline
Change in Y Balance Test (Lower Quarter)
Time frame: at baseline and 8 weeks after baseline
Time of return to sport activity (in days)
Time frame: within 8 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Faude, PD Dr. med. principal investigator
Department of Sport, Exercise and Health, Medical Faculty University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy program in people with Osgood-Schlatter Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Knee and Osteoarthritis Outcome Score for Children (KOOS-Child-Questionnaire Score) (time frame: at baseline and 8 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.