A Pilot Study on the Safety of Active Conservative Management of Low Grade Lumbar Stress Reactions in Adolescent Soccer Players
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in edema on MRI
研究概览
简要总结
Introduction: The Background
- Prevalence: Low back pain (LBP) is very common in young athletes, and lumbar spondylolysis (an overuse injury of bones in the low back) is the leading cause. In adolescent male soccer players with LBP, almost half (up to 48%) have this specific injury.
- The Current Standard: Existing Norwegian guidelines mandate a break from all sports for a minimum of 3 months when rehabilitating spondylolysis
- The Challenge: These strict guidelines lack strong evidence from clinical trials and can lead to negative social and physical consequences for the athlete, including exclusion from team activities and reduced general physical activity.
AIM: The Goal of the Study To determine the safety and effectiveness of a newly developed, 4-phased, pain-controlled rehabilitation protocol that uses early, criteria-based activity progression (based on functional capacity and pain levels) for youth football players diagnosed with spondylolysis.
Method: Study Design and Measurements
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Design: This is a pilot study (prospective cohort study) involving 30-40 youth football players with a first-time diagnosis of low grade (1-2) spondylolysis.
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Diagnosis: The injury is confirmed using an MRI scan (specifically the VIBE sequence).
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Data Collection: We will gather data through:
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MRIs: Comparing images at baseline (start) and after 3 months.
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Standardized Clinical Examinations.
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PROMs (Patient-Reported Outcome Measures - standardized questionnaires about function and pain).
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Weekly reporting on pain intensity and training volume.
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Outcome: We will compare the changes in the bone healing seen on the MRI findings between the start and end of the 3-month period, and at six months if applicable.
详细描述
Project description - A pilot study on the safety of active conservative management of lumbar stress reactions grade 1 in adolescent soccer players Bone stress injuries are often classified as either high or low risk injuries. High risk injuries are those injuries at sites prone to progressing to a complete fracture and delayed/non-union whereas low risk injuries have a more favourable natural history and have little need for surgery or prolonged weight-bearing restrictions . Lumbar spondylolysis (LS) is traditionally classified as one of these high-risk injuries.
LS is a bone stress injury in a vertebra. It occurs in the pars interarticularis, at times with additional posterior structures involved, and the most common site is L5 followed by L4. These injures can by graded from 0 to 4 according to the Hollenberg Classification.
LBP is reported as a common problem in soccer and is experienced by more than half of the young soccer players. LS is reported to be the most common source of low back pain (LBP) in adolescent athletes, and the incidence in adolescent athletes is two to five times higher than that in nonathletes. One study found that 48% of adolescent male soccer players with LBP had LS.
In the course of the primary investigators clinical work with talented adolescent soccer players the primary investigators encountered several cases of LS, most of whom were connected to academies. In the literature, only found five articles specifically focusing on this condition in adolescent soccer players were found. Studies show that if someone has a lumbar bone stress injury and cease to play football and other physical activities, they will most likely recover. This is in line with current treatment guidelines, classifying LS as a high-risk injury, and the recommended treatment is a minimum of three months of soccer cessation.
However, it has also been shown that adolescent soccer players with bone marrow edema that continue to play doesn't necessary get worse, i.e. none of the studies report on any player getting a spondylolisthesis. One study found that 100% of the grade 1 injuries healed on MRI, while only 80% of grade 3 injuries recovered. This raises a question whether LS should be treated according to its grade instead of as a homogenous diagnosis, with grade 1 being a low-risk injury. This could potentially reduce the disadvantages that comes with current practice (3 months cessation of soccer), such as drop out from soccer, negative psychosocial effects and deconditioning with possible increased risk of new/other injuries at RTP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Soccer players
- •Low grade (1-2) lumbar stress reaction in L4 or L
- •Pain in the area of the affected vertebrae with sports activity and/or ADL.
排除标准
- •Not able to get MRI,
- •Other conditions/injuries that potentially could affect the result (at baseline and during follow up), i.e. lumbar disc prolapse, scheurmans disease, ankylosing spondylitis,
- •Disorders influencing growth.
- •Previously unsuccessful treatment of lumbar stress reaction.
研究组 & 干预措施
Active rehabilitation of low grade lumbar spondylolysis
干预措施: Active rehabilitation protocol (Other)
结局指标
主要结局
Change in edema on MRI
时间窗: Baseline, 3 months and potentially at 6 months.
Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis. An addiotonal MR will be performed at 6 months for patients with the same or higher classification on the Hollenberg Critera at the 3 month follow-up
次要结局
- Changes in Youth Back Activity Questionnaire - norwegian version(Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks)
- Changes in Oswestry Disability Index(Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks)
研究者
Bård Bogen
Professor
Western Norway University of Applied Sciences