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

Background: Osgood-Schlatter is the most frequent growth-related injury affecting about 10% of physically active adolescents. It can cause long-term pain and limitations in sports and physical activity, with potential sequela well into adulthood. The management of Osgood-Schlatter is very heterogeneous. Recent systematic reviews have found low level evidence for surgical intervention and injection therapies, and an absence of studies on conservative management. Recently, a novel self-management approach with exercise, education, and activity modification, demonstrated favorable outcomes for adolescents with patellofemoral pain and Osgood-Schlatter in prospective cohort studies. Aim: The aim of this trial is to assess the effectiveness of the novel self-management approach compared to usual care in improving self-reported knee-related function in sport (measured using the KOOS-child ‘Sport/play’ subscale) after a 5-month period. Methods: This trial is a pragmatic, assessor-blinded, randomized controlled trial with a two-group parallel arm design, including participants aged 10–16 years diagnosed with Osgood-Schlatter. Participants will receive 3 months of treatment, consisting of either usual care or the self-management approach including exercise, education, and activity modification, followed by 2 months of self-management. Primary endpoint is the KOOS-child ‘Sport/play’ score at 5 months. This protocol details the planned methods and procedures. Discussion: The novel approach has already shown promise in previous cohort studies. This trial will potentially provide much-needed level 1 evidence for the effectiveness of the self-management approach, representing a crucial step towards addressing the long-term pain and limitations associated with Osgood-Schlatter. Trial registration: Clinicaltrials.gov: NCT05174182. Prospectively registered December 30th 2021. Date of first recruitment: January 3rd 2022. Target sample size: 130 participants.