Krommes Kasper, Thorborg Kristian, Clausen Mikkel Bek, Rathleff Michael Skovdal, Olesen Jens Lykkegaard, Kallemose Thomas, Hölmich Per
Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Amager-Hvidovre, Copenhagen University Hospital, Kettegaard Allé 30, Hvidovre, DK-2650, Denmark.
Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, DK-2200, Copenhagen N, Denmark.
BMC Sports Sci Med Rehabil. 2024 Apr 20;16(1):89. doi: 10.1186/s13102-024-00870-0.
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.
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.
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.
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.
Clinicaltrials.gov: NCT05174182. Prospectively registered December 30th 2021. Date of first recruitment: January 3rd 2022. Target sample size: 130 participants.
奥斯古德-施拉特病是最常见的与生长相关的损伤，约10%的活跃青少年受其影响。它可导致长期疼痛，并限制运动和体育活动，甚至可能产生持续到成年期的潜在后遗症。奥斯古德-施拉特病的治疗方法非常多样。最近的系统评价发现，手术干预和注射治疗的证据级别较低，且缺乏关于保守治疗的研究。最近，一种包括运动、教育和活动调整的新型自我管理方法，在前瞻性队列研究中显示对患有髌股疼痛和奥斯古德-施拉特病的青少年有良好效果。
本试验的目的是评估与常规护理相比，这种新型自我管理方法在5个月后改善自我报告的运动中膝关节相关功能（使用儿童膝关节损伤和骨关节炎疗效评分量表“运动/玩耍”子量表测量）的有效性。
本试验是一项实用的、评估者盲法的随机对照试验，采用两组平行臂设计，纳入年龄在10至16岁、被诊断为奥斯古德-施拉特病的参与者。参与者将接受3个月的治疗，治疗方式为常规护理或包括运动、教育和活动调整的自我管理方法，随后进行2个月的自我管理。主要终点是5个月时的儿童膝关节损伤和骨关节炎疗效评分量表“运动/玩耍”得分。本方案详细说明了计划采用的方法和程序。
这种新型方法在之前的队列研究中已显示出前景。本试验可能会为自我管理方法的有效性提供急需的一级证据，这是朝着解决与奥斯古德-施拉特病相关的长期疼痛和限制迈出的关键一步。
Clinicaltrials.gov：NCT05174182。2021年12月30日前瞻性注册。首次招募日期：2022年1月3日。目标样本量：130名参与者。
