Clinical trial NCT05174182: A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter
Official title: A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osgood-Schlatter Disease
Apophysitis
Osteochondrosis; Tibia
Physeal Injury
Keywords: Adolescents
Sport
Physical activity
Knee
Load management
Strength training
Accelerometer
Ultrasound
Tibial tubercle
Handheld dynamometry
Handheld algometry
Usual Care
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: University College Copenhagen
First posted: 2021-12-30
Enrollment: 130
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
timeFrame: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
Secondary outcomes:
measure: Patient Acceptable Symptom State change from baseline
timeFrame: 5 months
measure: Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline
timeFrame: 5 months
measure: Frequency of Pain Flares
timeFrame: 5 months
measure: Pain Flare Intensity change from baseline
timeFrame: 5 months
measure: Hours of Sports Participation
timeFrame: 5 months
measure: Hours of Physical Activity
timeFrame: 5 months
measure: Satisfaction with extent of sports participation change from baseline
timeFrame: 5 months
measure: Tendinosis signs change from baseline
timeFrame: 5 months
measure: Infrapatellar bursitis signs change from baseline
timeFrame: 5 months
measure: Flaviis composite severity score change from baseline
timeFrame: 5 months
measure: Anterior Knee Pain Provocation test change from baseline
timeFrame: 5 months
measure: Pain during knee extension strength test change from baseline
timeFrame: 5 months
measure: Pressure-pain threshold at the tibial tubercle change from baseline
timeFrame: 5 months
measure: Maximal isometric knee extension strength change from baseline
timeFrame: 5 months
measure: Countermovement jump height change from baseline
timeFrame: 5 months
measure: Global rating of Change
timeFrame: 5 months
measure: Patient-specific function scale change from baseline
timeFrame: 5 months
measure: Kinesiophobia change from baseline
timeFrame: 5 months
measure: Self-rated health change from baseline
timeFrame: 5 months
Other outcomes:
measure: Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Pain' Subscale change from baseline
timeFrame: 5 months
measure: Level of pain/discomfort change from baseline
timeFrame: 5 months
measure: Level of sports participation compared to before knee pain
timeFrame: 5 months
measure: Level of physical activity compared to before knee pain
timeFrame: 5 months
measure: Time to return to sport
timeFrame: 5 months
measure: Hyperemia of the tibial tubercle change from baseline
timeFrame: 5 months
measure: Palpation pain of the tibial tubecle
timeFrame: 5 months
measure: Pain during Countermovement Jump Test change from baseline
timeFrame: 5 months
measure: Countermovement jump power change from baseline
timeFrame: 5 months
measure: Knee extensor flexibility change from baseline
timeFrame: 5 months
measure: Satisfaction with treatment
timeFrame: 5 months
measure: Problems with usual activities change from baseline
timeFrame: 5 months
measure: Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Symptoms' change from baseline
timeFrame: 5 months
measure: Harms and adverse events
timeFrame: 5 months
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Copenhagen University Hospital, Amager-Hvidovre, Denmark
name: Kasper Krommes
role: STUDY_DIRECTOR
References: