Terminé

SOGOODA Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)

Ce qui est testé

A novel treatment approach

+ Usual care

Autre

Qui peut participer

Maladies osseuses

+ Maladies musculo-squelettiques

+ Ostéochondrose

De 10 à 16 ans

+11 critères d'éligibilité

Voir tous les critères d'éligibilité

Comment se déroule l'étude

Étude thérapeutique

Interventionnel

Date de début : janvier 2022

Voir le détail du protocole

Résumé

Sponsor principalHvidovre University Hospital

Dernière mise à jour : 28 janvier 2026

Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 janvier 2022

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielA Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)

NCT05174182

Sponsor principalHvidovre University Hospital

Dernière mise à jour : 28 janvier 2026

Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.

Détails du design

130 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.

Conditions

Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 10 à 16 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies osseusesMaladies musculo-squelettiquesOstéochondrose

Critères

5 critères d'inclusion nécessaires pour participer

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

Voir plus de critères

6 critères d'exclusion empêchent la participation

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

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.

Groupes de traitement

Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo.

Groupes de traitement

Groupe I

Expérimental

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.

Groupe II

Comparateur actif

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).

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Hvidovre Hospital

Hvidovre, DenmarkOuvrir Hvidovre Hospital dans Google Maps

Terminé1 Centres d'Étude