Osgood-Schlatter DiseaseQUICKRETURNOSDNCT05826340
Getting Kids With Osgood Schlatter Back to Performing Without Pain
A study testing Tailored progressive loading and return to sport and Pain guided activity in people with Osgood-Schlatter Disease, run by Aalborg University at 1 site in Denmark.
Trial summary
The goal of this trial is to compare graded return to sport, or pain guided activity to rest in youth with Osgood Schlatter. The main objectives are: to assess the graded return to sport, or pain guided activity on symptoms (pain and function) at six months compared to rest The secondary objectives are to assess the… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Osgood-Schlatter Disease
- What is being tested?
- Tailored progressive loading and return to sport and Pain guided activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jan 2023to Dec 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children/adolescents (male and female) aged 8-16 years
- Diagnosis of OSD based on clinical examination including localised pain at the tibial tuberosity (the insertion of the patellar tendon onto the shin) that increases by palpation, and pain during resisted isometric knee extension.
- Ability to understand and the willingness to provide consent
Who cannot join
- Any other diagnosable knee pathology, patellar instability, and patellofemoral instability.
- Previous knee surgery
- Habitual patella subluxation
- Clinical suspicion of meniscal lesion
- Previous neurologic, musculoskeletal or mental illnesses
- Other chronic conditions that may affect the involved musculoloskeletal/connective tissues and treatment (autoimmune, metabolic disorders, diabetes, etc.)
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
Michael S Rathleff, DrMed contact
Denmark1 site, 1 recruiting
- Recruiting
Research Unit for General Practice in Aalborg
Aalborg, 9220
Sinead Holden, quickreturnHST@aau.dk
About this study
Official title: A 3-arm Randomised Parallel Group Superiority Trial to Investigate the Efficacy of Graded Loading and Return to Sport or Pain Guided Activity, Versus Rest or on Symptom and Disease Severity in Patients With Osgood Schlatter
The goal of this trial is to compare graded return to sport, or pain guided activity to rest in youth with Osgood Schlatter. The main objectives are:
- to assess the graded return to sport, or pain guided activity on symptoms (pain and function) at six months compared to rest
The secondary objectives are to assess the impact of progressive return to sport or pain guided activity on:
- Muscle strength and performance
- Anterior knee pain provocation
- Sports participation
- Physical activity
The exploratory objectives are to assess the impact of progressive return to sport on ultrasound imaging characteristics of OSD.
Read the detailed description
Osgood Schlatter disease (OSD) affects 10% of adolescents aged 9-15. This makes it the most common knee pain condition in this age group. OSD is considered an overuse injury, common in highly sports active adolescents. It is considered an apophyseal injury of the tibial tuberosity, the site of attachment of the patellar tendon onto the tibia. Repetitive forces exerted on tissues without allowing for recovery can cause pain and/or tissue damage at the site of attachment onto the weak developing apophyseal cartilage which is thought to be a susceptible injury before the apophysis is fully matured. Characteristics such as cartilage swelling, and associated tendon changes (including thickening of the patellar tendon and increased doppler activity) have been documented.
Despite narrative reviews recommending conservative management, there is a complete lack of clinical research evaluating the different recommendations, which range from passive interventions, such as rest/activity limitation, to more active approaches including strength exercises for the lower extremity. We have developed a new progressive return to sport intervention approach which has been piloted in adolescents with OSD. The targeted intervention aims to balance recovery, and graded loading in a guided return to sport paradigm The goal is to help support adolescents manage pain, and guide return to sport \& function.
There is a need to test other potential conservative interventions which have yet to be examined in a randomised manner. Multi-arm trials allow more treatments to be assessed than a standard two arm trial. This makes this design simpler, quicker and cheaper than running multiple two arm trials, which will produce contemporaneous results for all treatments. This is relevant in the context of OSD, where none of the conservative recommendations have been evaluated. Despite rest being advocated, it may be possible to allow adolescents to participants to participate in sports to the extent that pain allows (pain guided activity). This may be beneficial, given the social and health consequences of complete withdrawal from sport. We therefore aim to evaluate both the progressive return to sport paradigm and pain guided activity in a 3-armed randomised trial, compared to advice to rest and withdrawal from sports.
- Conditions
- Osgood-Schlatter Disease
- Being tested
- Tailored progressive loading and return to sport, Pain guided activity
- Keywords
- Growth, Adolescent, Musculoskeletal, Pain, Osteochondrosis
- Medical subject headings
- Osteochondrosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored progressive loading and return to sportBehavioural
Also called Progressive return to sport
Participants will undergo a 5-stage progressive return to sport tool.
Pain guided activityBehavioural
Participants will be provided on information on how to guide activity based on pain response.
| Study group | Role | What they receive |
|---|---|---|
| Tailored loading | Experimental | Participants will be provided with a 5-stage return to sport tool, which gradually increases sports intensity and knee loading. In addition, they are to perform a progressive exercise program at home to increase lower extremity strength and prepare them for the demands of sport. Participants will begin at a starting point in the five stages based on their current symptoms and self reported sports related disability, and given guidance on how to progress / regress their loading within the five stage framework Receives: Behavioral: Tailored progressive loading and return to sport |
| Pain within acitvity limits | Experimental | Participants will be advised to participate in sport/exercise to the extent that pain allows. They will not be restriced full from sport but will be instructed how to use a pain moritoring tool to help monitor pain and balance the amount of activities in which they can participate. Receives: Behavioral: Pain guided activity |
| Rest until pain subsides | No intervention | Participants will be provided advice on rest for a minimum of four weeks or until pain subsides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be captured using a visual analogue scale (VAS) ranging from 0cm (no pain) to 10cm (worst pain imaginable) where participants are asked to rate their worth pain in the previous week.
Measured: 6 months
Sports related function
The patient reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS) contains five separate subscales. We will use the KOOS-Child Sport/Rec subscale to assess sports related function.The scale ranges from 0-100, with higher scores indicating better outcomes
Measured: 6 months
Secondary outcomes (10)
Health related quality of life
Health related quality of life will be measured by the youth version of the European Quality of Life 5 Dimensions (EQ-5D-Y) at baseline, 3months, 6 months and 12months. The index score ranges from 0-1, with 1 indicating full health.
Measured: 3 months, 6 months, 12 months
Muscle strength and performance
Isometric knee extension torque, hip abduction, and hip extension torque will be measured using a handheld dynamometer. Participants will perform three maximal effort contractions. Results will be averaged and normalised to body weight and lever length.
Lower limb power will be conducted by asking the participants to perform single leg vertical and horizontal jumps.
Measured: 6 months
Sports participation
Adolescents will report their weekly sports volume (expressed in hours per week).
Measured: 3months, 6months, 12 months
Return to sport
In case of any absence from sport, the time to return to sport (i.e. duration of absence) will be documented.
Measured: 3months, 6months, 12 months
Objective physical activity
Participants will be provided with an Actigraph monitor for two weeks to objectively measure physical activity (time spent in moderate to vigorous physical activity and sedentary time at 6 months follow-up. The specific model used will be the wGT3X- BT actigraphy device (ActiGraphCorp, Pensacola, FL), which is a compact, wrist- worn, battery-powered, CE marked device that captures and records continuous, high resolution physical activity and sleep/wake information.
Measured: 6 months
Pain severity during palpation
Numeric rating scale ranging from 0, no pain to 10 worst imaginable pain) in response to palpation of the tibial tuberosity.
Measured: 6 months
Pain severity during knee loading
Numeric rating scale ranging from 0, no pain to 10 worst imaginable pain) in response to the anterior knee pain provocation (AKPP). Participants will be asked to complete a single leg squat to about 60 degrees of knee flexion and hold the position for 30 seconds. Pain will be recorded at the end of 30 seconds.
Measured: 6 months
Global rating of change
Self-reported recovery on a 7-point Likert scale, ranging from much better, to much worse.
Measured: 3 months, 6 months, 12 months
Pain intensity
Pain intensity will be captured using a visual analogue scale (VAS) ranging from 0cm (no pain) to 10cm (worst pain imaginable) where participants are asked to rate their worth pain in the previous week.
Measured: 3 months, 12 months
Sports related function
The patient reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS)[22] contains five separate subscales. We will use the KOOS-Child Sport/Rec subscale to assess sports related function. This scale ranges from 0-100 with higher scores reflecting better outcomes
Measured: 3 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start26 Jan 2023
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinead Holden, Aalborg University
- Investigators
- Sinead Holden, PhD, Principal investigator, Aalborg UniversityMichael S Rathleff, Dr. Med, Principal investigator, Aalborg UniversityJens Olesen, Principal investigator, Centre for Almen Medicin ved Aalborg Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826340
- Sponsor's protocol ID
- Quick Return OSD 001
- Other IDs
- N-20210052
- Acronym
- QUICKRETURNOSD
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be managed according to the FAIR principles (findable, accessible, inter-operable and reproducible). Meta-data will be uploaded to Open Science framework with restrictions and terms for accessing the anonymised data according for research purposes, where appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-arm Randomised Parallel Group Superiority Trial to Investigate the Efficacy of Graded Loading and Return to Sport or Pain Guided Activity, Versus Rest or on Symptom and Disease Severity in Patients With Osgood Schlatter
- ClinicalTrials.gov ID
- NCT05826340
- Acronym / sponsor ID
- QUICKRETURNOSD / Quick Return OSD 001
- Conditions
- Osgood-Schlatter Disease
- Keywords
- Growth, Adolescent, Musculoskeletal, Pain, Osteochondrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Apr 2023 (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 goal of this trial is to compare graded return to sport, or pain guided activity to rest in youth with Osgood Schlatter. The main objectives are:
- to assess the graded return to sport, or pain guided activity on symptoms (pain and function) at six months compared to rest
The secondary objectives are to assess the impact of progressive return to sport or pain guided activity on:
- Muscle strength and performance
- Anterior knee pain provocation
- Sports participation
- Physical activity
The exploratory objectives are to assess the impact of progressive return to sport on ultrasound imaging characteristics of OSD.
Detailed description
Osgood Schlatter disease (OSD) affects 10% of adolescents aged 9-15. This makes it the most common knee pain condition in this age group. OSD is considered an overuse injury, common in highly sports active adolescents. It is considered an apophyseal injury of the tibial tuberosity, the site of attachment of the patellar tendon onto the tibia. Repetitive forces exerted on tissues without allowing for recovery can cause pain and/or tissue damage at the site of attachment onto the weak developing apophyseal cartilage which is thought to be a susceptible injury before the apophysis is fully matured. Characteristics such as cartilage swelling, and associated tendon changes (including thickening of the patellar tendon and increased doppler activity) have been documented.
Despite narrative reviews recommending conservative management, there is a complete lack of clinical research evaluating the different recommendations, which range from passive interventions, such as rest/activity limitation, to more active approaches including strength exercises for the lower extremity. We have developed a new progressive return to sport intervention approach which has been piloted in adolescents with OSD. The targeted intervention aims to balance recovery, and graded loading in a guided return to sport paradigm The goal is to help support adolescents manage pain, and guide return to sport \& function.
There is a need to test other potential conservative interventions which have yet to be examined in a randomised manner. Multi-arm trials allow more treatments to be assessed than a standard two arm trial. This makes this design simpler, quicker and cheaper than running multiple two arm trials, which will produce contemporaneous results for all treatments. This is relevant in the context of OSD, where none of the conservative recommendations have been evaluated. Despite rest being advocated, it may be possible to allow adolescents to participants to participate in sports to the extent that pain allows (pain guided activity). This may be beneficial, given the social and health consequences of complete withdrawal from sport. We therefore aim to evaluate both the progressive return to sport paradigm and pain guided activity in a 3-armed randomised trial, compared to advice to rest and withdrawal from sports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored loading | Experimental | Behavioral: Tailored progressive loading and return to sportParticipants will be provided with a 5-stage return to sport tool, which gradually increases sports intensity and knee loading. In addition, they are to perform a progressive exercise program at home to increase lower extremity strength and prepare them for the demands of sport. Participants will begin at a starting point in the five stages based on their current symptoms and self reported sports related disability, and given guidance on how to progress / regress their loading within the five stage framework |
| Pain within acitvity limits | Experimental | Behavioral: Pain guided activityParticipants will be advised to participate in sport/exercise to the extent that pain allows. They will not be restriced full from sport but will be instructed how to use a pain moritoring tool to help monitor pain and balance the amount of activities in which they can participate. |
| Rest until pain subsides | No intervention | –Participants will be provided advice on rest for a minimum of four weeks or until pain subsides |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children/adolescents (male and female) aged 8-16 years
- Diagnosis of OSD based on clinical examination including localised pain at the tibial tuberosity (the insertion of the patellar tendon onto the shin) that increases by palpation, and pain during resisted isometric knee extension.
- Ability to understand and the willingness to provide consent
Key exclusion criteria (7 listed)
- Any other diagnosable knee pathology, patellar instability, and patellofemoral instability.
- Previous knee surgery
- Habitual patella subluxation
- Clinical suspicion of meniscal lesion
- Previous neurologic, musculoskeletal or mental illnesses
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 |
|---|---|---|
| Tailored progressive loading and return to sportAlso: Progressive return to sportParticipants will undergo a 5-stage progressive return to sport tool. | Behavioural | Tailored loading |
| Pain guided activityParticipants will be provided on information on how to guide activity based on pain response. | Behavioural | Pain within acitvity limits |
Primary outcome
Pain intensity
Time frame: 6 months
Pain intensity will be captured using a visual analogue scale (VAS) ranging from 0cm (no pain) to 10cm (worst pain imaginable) where participants are asked to rate their worth pain in the previous week.
Sports related function
Time frame: 6 months
The patient reported questionnaire Knee Injury and Osteoarthritis Outcome Score (KOOS) contains five separate subscales. We will use the KOOS-Child Sport/Rec subscale to assess sports related function.The scale ranges from 0-100, with higher scores indicating better outcomes
10 secondary outcomes
Health related quality of life
Time frame: 3 months, 6 months, 12 months
Muscle strength and performance
Time frame: 6 months
Sports participation
Time frame: 3months, 6months, 12 months
Return to sport
Time frame: 3months, 6months, 12 months
Objective physical activity
Time frame: 6 months
Pain severity during palpation
Time frame: 6 months
Pain severity during knee loading
Time frame: 6 months
Global rating of change
Time frame: 3 months, 6 months, 12 months
Pain intensity
Time frame: 3 months, 12 months
Sports related function
Time frame: 3 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: Yes. Data will be managed according to the FAIR principles (findable, accessible, inter-operable and reproducible). Meta-data will be uploaded to Open Science framework with restrictions and terms for accessing the anonymised data according for research purposes, where appropriate.
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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.
Michael S Rathleff, DrMed contact
Sinead Holden, PhD principal investigator
Aalborg University
Michael S Rathleff, Dr. Med principal investigator
Aalborg University
Jens Olesen principal investigator
Centre for Almen Medicin ved Aalborg Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored progressive loading and return to sport and Pain guided activity in people with Osgood-Schlatter Disease, run by Aalborg University 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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael S Rathleff, DrMed (quickreturnOSD@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 6 months). The study lists 2 primary outcomes in all. 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 24 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.