Osgood-Schlatter DiseaseSOGOODNCT05174182
A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter
A study testing A novel treatment approach in people with Osgood-Schlatter Disease and Apophysitis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The most common growth-related injury is Osgood Schlatter, which affects up to 1 in 5 physically active adolescents. It can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Osgood-Schlatter Disease, Apophysitis, Osteochondrosis; Tibia
- What is being tested?
- A novel treatment approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 8 Mar 2024
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tenderness on palpation of the tibial tuberosity or pain during resisted isometric knee extensions
- Insidious onset of pain or swelling of the tibial tuberosity for ≥6 weeks
- Provoked by at least 2 of the following positions or activities; prolonged sitting or kneeling, squatting, running, hopping/jumping, stair walking or during multidirectional sports
- Clinical diagnosis of Osgood Schlatter
- Markedly reduced sports participation OR severely affected by pain during sports participation
Who cannot join
- Other primary pathology or complaints from other structures of the knee
- Other injuries, complaints or illnesses that may cause disability, or specifically restricts levels of physical activity or sports participation
- Previous surgery in the lower extremities or lumbar spine
- Congenital deformities, device implants og cysts og tumors of the knee
- Participants not willing to cease concomitant treatment
- Participants and their parents not able to understand and communicate in written and verbal Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)
The most common growth-related injury is Osgood Schlatter, which affects up to 1 in 5 physically active adolescents. It can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. No effective conservative treatments have been documented, and clinical practice is characterized by a wealth of conflicting advice and modalities. A novel treatment approach has shown promising results in a small single-cohort study. Therefore, this study aims to compare this novel treatment with usual care in 10-16-year-old adolescents with Osgood Schlatter.
This single-center pragmatic, double-blinded, randomized, controlled superiority trial, will have a two-group parallel arm design. Participants will undergo 3 months of treatment, followed by 2 months of self-management with self-reported knee function (KOOS-child 'Sport/rec') at 5 months as the primary endpoint.
This trial comparing a novel treatment with usual care for adolescents with Osgood Schlatter could result in an evidence-based treatment ready for implementation in clinical practice, benefitting patients outcomes and clinicians.
- Being tested
- A novel treatment approach, Usual care
- Keywords
- Adolescents, Sport, Physical activity, Knee, Load management, Strength training, Accelerometer, Ultrasound, Tibial tubercle, Handheld dynamometry, Handheld algometry, Usual Care
- Medical subject headings
- Osteochondrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel treatment approachOther
A novel treatment approach, as described before.
Usual careOther
Usual care, as described before.
| Study group | Role | What they receive |
|---|---|---|
| A novel treatment approach | Experimental | The experimental intervention were first comprised and tested in a large cohort of 10-14-year-old adolescents with a similar condition (patellofemoral pain) and was associated with a successful outcome after 12 weeks.
Afterwards, the intervention was changed slightly to target adolescents with Osgood Schlatter and then pilot-tested in a cohort of 51 participants. In this cohort, most participants needed more time to progress through exercises and sport, and the investigators have therefore piloted extending the intervention further in the clinic, with more success on these aspects.
The experimental intervention will contain an active approach with self-management of load and progressive exercise therapy throughout the treatment course, delivered through 4 one-on-one visits lasting approximately 20 minutes (at months 0, 1, 2, 3) with a physiotherapist and an accompanying leaflet with written and illustrated exercise description, and advice and information. Receives: Other: A novel treatment approach |
| Usual care | Active comparator | The investigators have performed a step-wise mixed-methods sub-study to investigate current standard of care in the most common settings in Denmark (Sports Physiotherapists mainly from private primary practice, and Orthopedic Surgeons caring for these patients, invited from all public secondary care orthopedic departments in Denmark). Results were then combined with reports from patients seen in the clinic (n=34) who were questioned in detail on what modalities and advice they had previously received. The results were mostly compatible with the recent international survey of clinicians treating Osgood-Schlatter. With the findings from this process the investigators have developed a patient-aimed leaflet, which will contain vignettes and elaborations of the multimodal approaches included in the standardized usual care package, which will be implemented through four visits (at months 0, 1, 2, 3) with a physiotherapist (mirroring the plan of care of the experimental group). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
Secondary outcomes (19)
Patient Acceptable Symptom State change from baseline
The question pertaining to Patient Acceptable Symptom State (PASS) are designed in collaboration with patient representatives. The recall period will be one week, and the outlook period a 'few months' as in previous applications in musculoskeletal conditions with fluctuating symptoms:
"If you consider your knee pain during the past week, and how it affects your ability to do activities of daily living (for example participating in school, in sports, and socially), would you consider your current symptom state acceptable for the next few months?". The proportions of yes/no in each group will be captured
Measured: 5 months
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline
The scale contains 6 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: 5 months
Frequency of Pain Flares
Weekly average of pain flares over a 4-week period leading up to the 5 months visit. Pain flares are defined as episodes of of 4 or more on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Measured: 5 months
Pain Flare Intensity change from baseline
Pain intensity as defined as the highest rating of pain on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Measured: 5 months
Hours of Sports Participation
The level of participation in sports will be captured through weekly monitoring. Participants will be asked if they have been participating in sports in the preceding week, and for how many hours. A 4-week average leading up to the 5 month visit will be calculated
Measured: 5 months
Hours of Physical Activity
Minutes of Moderate to Vigorous Physical Activity (MVPA) will be captured using waterproof 3 axis 12 Hz accelerometers (SENS®, Copenhagen, Denmark) applied once to the participants thigh during the enrollment visit using an adhesive patch. A 4-week average leading up to the 5 month visit will be calculated
According to WHO recommendations a daily minimum of 60 min of MVPA is needed to stay healthy for 5-17 year olds.Thus being at either under or above this cutoff during a 4-week average leading up to the 5 month visit will be assessed, in addition to a continuous comparison between the two groups of minutes of MVPA during the same time period.
Measured: 5 months
Satisfaction with extent of sports participation change from baseline
Participants will also be asked during clinical visits if they are satisfied with the current extent of their sports participation (Yes/No questions).
Measured: 5 months
Tendinosis signs change from baseline
Involvement of the tendon is common in patients with Osgood Schlatter. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the tendon as thickened or with hyperemia through color-doppler mode.
Measured: 5 months
Infrapatellar bursitis signs change from baseline
In Osgood-Schlatter patients, associated signs of bursitis have shown to be prognostic of a worse outcome. Signs of tendinosis will be assess through ultrasound scanning by evaluating either the infrapatellar bursa as thickened or with hyperemia through color-doppler mode.
Measured: 5 months
Flaviis composite severity score change from baseline
In Osgood-Schlatter patients, gradings of severity have shown to be prognostic of a worse outcome. Severity will be graded according to the ad modum Flaviis 1-4 grading, or as 'normal'.
Measured: 5 months
Anterior Knee Pain Provocation test change from baseline
Adolescents will rate their pain from performing the Anterior Knee Pain Provocation test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Measured: 5 months
Pain during knee extension strength test change from baseline
Adolescents will rate pain experienced during a maximal isometric knee extension strength test on the 0-10 numerical pain rating scale with 0 being no pain and 10 being worst pain imaginable.
Measured: 5 months
Pressure-pain threshold at the tibial tubercle change from baseline
To evaluate local hyperalgesia specifically at the tibial tubercle, handheld algometry will be used to detect the pressure (kPa) needed to evoke pain (going from no pain to the slightest sensation of pain) on the tibial tubercle on both knees
Measured: 5 months
Maximal isometric knee extension strength change from baseline
To evaluate the capacity of the quadriceps femoris muscle inserting at the site of pain, handheld dynamometry will be used to measure maximal isometric force generation which will be normalized to bodyweight and lever-length (Nm/kg).
Measured: 5 months
Countermovement jump height change from baseline
As a measure of sports-specific skill, a countermovement jump will be performed to record jump height (cm), using high-speed video analysis via a smartphone app (My Jump 2).
Measured: 5 months
Global rating of Change
To assess patient-assessed improvement or worsening, study personnel will ask participants to rate their perceived level of change from their first visit on a 7-point likert scale ranging from 'Much worse' to 'Much better'.
Measured: 5 months
Patient-specific function scale change from baseline
Study personnel will ask participants to rate their problems with an important activity using the Patient-Specific Functional Scale. They are asked to name a single important activity of their own choosing. Participants then rate their functional limitation with activity on a 0 to 10 scale, where 0 corresponds to being unable to perform activity and 10 is being able to perform activity at same level as before knee pain.
Measured: 5 months
Kinesiophobia change from baseline
To capture level of kinesiophobia, that is, the fear of pain due to movement or exercise, a type of fear-avoidance behavior, the patient-reported 17-item Tampa Scala of Kinesiophobia (TSK-17) will be used.
Measured: 5 months
Self-rated health change from baseline
Self-rated health will be collected through the 0-100 VAS for general health.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jan 2022
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is a single-center pragmatic, double-blinded randomized controlled superiority trial, with a two-group parallel arm design and 1:1 group allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, University College Copenhagen
- Responsible party
- Principal investigator, Kasper Krommes, Hvidovre University Hospital
- Investigators
- Kasper Krommes, Study director, Amager Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174182
- Sponsor's protocol ID
- H-21028912
- Acronym
- SOGOOD
- Status last verified
- Apr 2025
- First submitted
- 30 Nov 2021
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To increase transparency and dissemination, all statistical code and fully anonymized dataset will be shared to a open-access repository (such as YODA, Zenodo or Figshare) with a digital objective identifier once all planned publications are accepted or published as pre-print. Publication-specific datasets will potentially be posted along with published manuscripts in line with journal policies. If full anonymity cannot be achieved by removing unique data and identifies, a synthetic dataset will be created which will mimic the original dataset by preserving the statistical properties and the relationships between variables.
Publications
Krommes K, Thorborg K, Clausen MB, Rathleff MS, Olesen JL, Kallemose T, Holmich P. Self-management including exercise, education and activity modification compared to usual care for adolescents with Osgood-Schlatter (the SOGOOD trial): protocol of a randomized controlled superiority trial. BMC Sports Sci Med Rehabil. 2024 Apr 20;16(1):89. doi: 10.1186/s13102-024-00870-0.
PubMed 38643184
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)
- ClinicalTrials.gov ID
- NCT05174182
- Acronym / sponsor ID
- SOGOOD / H-21028912
- Keywords
- Adolescents, Sport, Physical activity, Knee, Load management, Strength training, Accelerometer, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University, University College Copenhagen
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 30 Dec 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.
The most common growth-related injury is Osgood Schlatter, which affects up to 1 in 5 physically active adolescents. It can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. No effective conservative treatments have been documented, and clinical practice is characterized by a wealth of conflicting advice and modalities. A novel treatment approach has shown promising results in a small single-cohort study. Therefore, this study aims to compare this novel treatment with usual care in 10-16-year-old adolescents with Osgood Schlatter.
This single-center pragmatic, double-blinded, randomized, controlled superiority trial, will have a two-group parallel arm design. Participants will undergo 3 months of treatment, followed by 2 months of self-management with self-reported knee function (KOOS-child 'Sport/rec') at 5 months as the primary endpoint.
This trial comparing a novel treatment with usual care for adolescents with Osgood Schlatter could result in an evidence-based treatment ready for implementation in clinical practice, benefitting patients outcomes and clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial is a single-center pragmatic, double-blinded randomized controlled superiority trial, with a two-group parallel arm design and 1:1 group allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| A novel treatment approach | Experimental | Other: A novel treatment approachThe experimental intervention were first comprised and tested in a large cohort of 10-14-year-old adolescents with a similar condition (patellofemoral pain) and was associated with a successful outcome after 12 weeks. Afterwards, the intervention was changed slightly to target adolescents with Osgood Schlatter and then pilot-tested in a cohort of 51 participants. In this cohort, most participants needed more time to progress through exercises and sport, and the investigators have therefore piloted extending the intervention further in the clinic, with more success on these aspects. The experimental intervention will contain an active approach with self-management of load and progressive exercise therapy throughout the treatment course, delivered through 4 one-on-one visits lasting approximately 20 minutes (at months 0, 1, 2, 3) with a physiotherapist and an accompanying leaflet with written and illustrated exercise description, and advice and information. |
| Usual care | Active comparator | Other: Usual careThe investigators have performed a step-wise mixed-methods sub-study to investigate current standard of care in the most common settings in Denmark (Sports Physiotherapists mainly from private primary practice, and Orthopedic Surgeons caring for these patients, invited from all public secondary care orthopedic departments in Denmark). Results were then combined with reports from patients seen in the clinic (n=34) who were questioned in detail on what modalities and advice they had previously received. The results were mostly compatible with the recent international survey of clinicians treating Osgood-Schlatter. With the findings from this process the investigators have developed a patient-aimed leaflet, which will contain vignettes and elaborations of the multimodal approaches included in the standardized usual care package, which will be implemented through four visits (at months 0, 1, 2, 3) with a physiotherapist (mirroring the plan of care of the experimental group). |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Tenderness on palpation of the tibial tuberosity or pain during resisted isometric knee extensions
- Insidious onset of pain or swelling of the tibial tuberosity for ≥6 weeks
- Provoked by at least 2 of the following positions or activities; prolonged sitting or kneeling, squatting, running, hopping/jumping, stair walking or during multidirectional sports
- Clinical diagnosis of Osgood Schlatter
- Markedly reduced sports participation OR severely affected by pain during sports participation
Key exclusion criteria (6 listed)
- Other primary pathology or complaints from other structures of the knee
- Other injuries, complaints or illnesses that may cause disability, or specifically restricts levels of physical activity or sports participation
- Previous surgery in the lower extremities or lumbar spine
- Congenital deformities, device implants og cysts og tumors of the knee
- Participants not willing to cease concomitant treatment
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 |
|---|---|---|
| A novel treatment approachA novel treatment approach, as described before. | Other | A novel treatment approach |
| Usual careUsual care, as described before. | Other | Usual care |
Primary outcome
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
Time frame: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
19 secondary outcomes
Patient Acceptable Symptom State change from baseline
Time frame: 5 months
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline
Time frame: 5 months
Frequency of Pain Flares
Time frame: 5 months
Pain Flare Intensity change from baseline
Time frame: 5 months
Hours of Sports Participation
Time frame: 5 months
Hours of Physical Activity
Time frame: 5 months
Satisfaction with extent of sports participation change from baseline
Time frame: 5 months
Tendinosis signs change from baseline
Time frame: 5 months
Infrapatellar bursitis signs change from baseline
Time frame: 5 months
Flaviis composite severity score change from baseline
Time frame: 5 months
Anterior Knee Pain Provocation test change from baseline
Time frame: 5 months
Pain during knee extension strength test change from baseline
Time frame: 5 months
Pressure-pain threshold at the tibial tubercle change from baseline
Time frame: 5 months
Maximal isometric knee extension strength change from baseline
Time frame: 5 months
Countermovement jump height change from baseline
Time frame: 5 months
Global rating of Change
Time frame: 5 months
Patient-specific function scale change from baseline
Time frame: 5 months
Kinesiophobia change from baseline
Time frame: 5 months
Self-rated health change from baseline
Time frame: 5 months
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 11 Apr 2025.
- Derived from this study: PubMed 38643184Krommes K, Thorborg K, Clausen MB, Rathleff MS, Olesen JL, Kallemose T, Holmich P. Self-management including exercise, education and activity modification compared to usual care for adolescents with Osgood-Schlatter (the SOGOOD trial): protocol of a randomized controlled superiority trial. BMC Sports Sci Med Rehabil. 2024 Apr 20;16(1):89. doi: 10.1186/s13102-024-00870-0.
- Individual participant dataSharing planned: Yes. To increase transparency and dissemination, all statistical code and fully anonymized dataset will be shared to a open-access repository (such as YODA, Zenodo or Figshare) with a digital objective identifier once all planned publications are accepted or published as pre-print. Publication-specific datasets will potentially be posted along with published manuscripts in line with journal policies. If full anonymity cannot be achieved by removing unique data and identifies, a synthetic dataset will be created which will mimic the original dataset by preserving the statistical properties and the relationships between variables.
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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.
Kasper Krommes study director
Amager Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel treatment approach in people with Osgood-Schlatter Disease and Apophysitis, run by Hvidovre University Hospital at 1 site 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 5 inclusion and 6 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 11 Apr 2025. 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 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?
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline (time frame: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)). 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 NCT05174182, 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 11 Apr 2025.