A Comparison of Two Different Treatment Approaches for Adolescents With Osgood Schlatter: A Randomized Controlled Superiority Trial (The SOGOOD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants: Participants are blinded to the actual contents of the two interventions before being allocated, and will remain blinded to the contents of the parallel intervention. They are also blinded to the superiority framework.
Care provider: Therapists delivering an intervention will likewise be blinded to the contents of the parallel intervention, and to the superiority framework.
Outcomes assessors: Staff collecting objective outcome data are blinded to group allocation of participants.
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual care
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).
干预措施: Usual care (Other)
A novel treatment approach
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.
干预措施: A novel treatment approach (Other)
结局指标
主要结局
Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Sport / Recreation' subscale change from baseline
时间窗: 5 months (secondary timepoints: month 1, 2, 3, 8, 10, 12, 24, 48)
The scale contains 7 questions answered through a 0-4 likert scale. The scale is normalized to a 0-100 score with 100 be, with zero representing extreme knee problems and 100 representing no knee problems.
次要结局
- Hours of Physical Activity(5 months)
- Hours of Sports Participation(5 months)
- Flaviis composite severity score change from baseline(5 months)
- Anterior Knee Pain Provocation test change from baseline(5 months)
- Pressure-pain threshold at the tibial tubercle change from baseline(5 months)
- Patient Acceptable Symptom State change from baseline(5 months)
- Pain Flare Intensity change from baseline(5 months)
- Tendinosis signs change from baseline(5 months)
- Kinesiophobia change from baseline(5 months)
- Pain during knee extension strength test change from baseline(5 months)
- Countermovement jump height change from baseline(5 months)
- Patient-specific function scale change from baseline(5 months)
- Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) 'Quality of Life' Subscale change from baseline(5 months)
- Frequency of Pain Flares(5 months)
- Satisfaction with extent of sports participation change from baseline(5 months)
- Global rating of Change(5 months)
- Infrapatellar bursitis signs change from baseline(5 months)
- Maximal isometric knee extension strength change from baseline(5 months)
- Self-rated health change from baseline(5 months)
研究者
Kasper Krommes
Senior Research Coordinator
Hvidovre University Hospital