Osgood Schlatter DiseaseNCT02799394
Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
A study testing Activity modification, exercises and gradual return to sport in people with Osgood Schlatter Disease, run by Aalborg University at 2 sites in Denmark.
Trial summary
The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Osgood Schlatter Disease
- What is being tested?
- Activity modification, exercises and gradual return to sport
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2016to Dec 2017
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10-14 years of age
- Pain at tuberositas patellae during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
- Pain during palpation of tuberositas patellae
- Knee pain for 6 weeks or more
Who cannot join
- Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
- Previous surgery
- Pain from the hip or back that interferes with activities of daily living.
- Habitual patella luxations
- Clinical suspicion of meniscal lesion
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg Universitetshospital
Aalborg, The North Denmark Region, 9000
Hvidovre-Amager Hospital
Hvidovre, 2650
About this study
The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The adolescents will be recruited from primary schools, general practitioners and through online advertising on Facebook.
- Conditions
- Osgood Schlatter Disease
- Being tested
- Activity modification, exercises and gradual return to sport
- Medical subject headings
- Osteochondrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity modification, exercises and gradual return to sportOther
| Study group | Role | What they receive |
|---|---|---|
| Activity modification, exercises and gradual return to sport | Experimental | Not described Receives: Other: Activity modification, exercises and gradual return to sport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported recovery on a 7-point Likert scale
Measured: 3 months
Secondary outcomes (8)
Self-reported recovery on a 7-point Likert scale
Measured: 4 and 8 weeks + 6 and 12 months after inclusion.
Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"
Measured: 4, 8 and 12 weeks + 6 and 12 months after inclusion.
Isometric hip and knee extension strength assessed using a strap-mounted dynamometer
Measured: 4, 8 and 12 weeks after inclusion.
Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.
Measured: 4, 8 and 12 weeks after inclusion.
Thigh circumference measured using tape measure.
Measured: 4, 8 and 12 weeks after inclusion.
Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]
Measured: 4, 8 and 12 weeks after inclusion.
Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).
Measured: 4, 8 and 12 weeks after inclusion.
Flexibility of the hamstrings and quadriceps [measured using goniometer].
Measured: 4, 8 and 12 weeks after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Skovdal Rathleff, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799394
- Sponsor's protocol ID
- N- 20140100-1
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made publicly available no later than six months after the final publication.
Publications
Rathleff MS, Winiarski L, Krommes K, Graven-Nielsen T, Holmich P, Olesen JL, Holden S, Thorborg K. Activity Modification and Knee Strengthening for Osgood-Schlatter Disease: A Prospective Cohort Study. Orthop J Sports Med. 2020 Apr 6;8(4):2325967120911106. doi: 10.1177/2325967120911106. eCollection 2020 Apr.
PubMed 32284945
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.
- ClinicalTrials.gov ID
- NCT02799394
- Acronym / sponsor ID
- N- 20140100-1
- Conditions
- Osgood Schlatter Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The adolescents will be recruited from primary schools, general practitioners and through online advertising on Facebook.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity modification, exercises and gradual return to sport | Experimental | Other: Activity modification, exercises and gradual return to sport |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 10-14 years of age
- Pain at tuberositas patellae during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
- Pain during palpation of tuberositas patellae
- Knee pain for 6 weeks or more
Key exclusion criteria (5 listed)
- Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
- Previous surgery
- Pain from the hip or back that interferes with activities of daily living.
- Habitual patella luxations
- Clinical suspicion of meniscal lesion
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 |
|---|---|---|
| Activity modification, exercises and gradual return to sport | Other | Activity modification, exercises and gradual return to sport |
Primary outcome
Self-reported recovery on a 7-point Likert scale
Time frame: 3 months
8 secondary outcomes
Self-reported recovery on a 7-point Likert scale
Time frame: 4 and 8 weeks + 6 and 12 months after inclusion.
Self-report questionnaire "Knee Injury and Osteoarthritis Outcome Score"
Time frame: 4, 8 and 12 weeks + 6 and 12 months after inclusion.
Isometric hip and knee extension strength assessed using a strap-mounted dynamometer
Time frame: 4, 8 and 12 weeks after inclusion.
Pressure pain thresholds at tuberositas patella, center of patella and lateral elbow assessed by a hand held pressure algometer.
Time frame: 4, 8 and 12 weeks after inclusion.
Thigh circumference measured using tape measure.
Time frame: 4, 8 and 12 weeks after inclusion.
Vertical jump for height [calculated as the difference between reach height and maximal jump height. This will be measured using a ruler]
Time frame: 4, 8 and 12 weeks after inclusion.
Single leg jump for distance (defined as the maximal length the subject can jump on one leg. Measured using a ruler).
Time frame: 4, 8 and 12 weeks after inclusion.
Flexibility of the hamstrings and quadriceps [measured using goniometer].
Time frame: 4, 8 and 12 weeks after inclusion.
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 30 Jan 2018.
- Derived from this study: PubMed 32284945Rathleff MS, Winiarski L, Krommes K, Graven-Nielsen T, Holmich P, Olesen JL, Holden S, Thorborg K. Activity Modification and Knee Strengthening for Osgood-Schlatter Disease: A Prospective Cohort Study. Orthop J Sports Med. 2020 Apr 6;8(4):2325967120911106. doi: 10.1177/2325967120911106. eCollection 2020 Apr.
- Individual participant dataSharing planned: Yes. Data will be made publicly available no later than six months after the final publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity modification, exercises and gradual return to sport in people with Osgood Schlatter Disease, run by Aalborg University at 2 sites in Denmark.
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 5 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. 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?
Self-reported recovery on a 7-point Likert scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799394, which also lists 1 linked publication.
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 30 Jan 2018.