跳至主要内容
临床试验/NCT05641857
NCT05641857已完成不适用

Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers

Orton Orthopaedic Hospital1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Low back pain (LBP)

研究概览

简要总结

The investigators will examine the prevalence of low-back pain and disc degeneration among Finnish elite skiers between 16 and 35 years of age and compare these findings with the data collected among healthy volunteers studied between 1994-2021.

详细描述

The study population will consist of Finnish elite cross-country skiers between 18 and 35 years of age. Invitation letters will be sent to all skiers who are selected to national teams at season 2022-2023. The study population for the current study will be approximately 100 individuals. Study protocol for the current study will consist of a semi-structured interview, clinical examination, lumbar spine MRI and patient reported outcome measures. All participants will sign an informed consent before commencement of the study. If a participant is younger than 18 years, also his/her caregiver will be asked for a signed consent.

The interview comprised of questions about the athletes training volume and possible LBP without associated trauma. (suspension from training or competition due to LBP, possible contacts to health-care providers).

Body height and weight were self-reported. Leg length inequality was assessed comparing the height of the left and right iliac crests in standing position with straight knees. Wooden blocks of different thickness (with 0.5 cm increment) were used for correction of possible leg length inequality. Symmetry of the back was measured in forward bending using a scoliometer.

From MRI (high field 1.5 T) the signal intensity of the nucleus pulposus will be assessed both qualitatively and quantitatively. The midline T2-weighted images will be independently evaluated visually by three evaluators using a Pfirrmann classification. The quantitative nucleus signal intensities will be assessed by two evaluators using a relative measure comparing the signal intensity of the nucleus pulposus to that of the adjacent cerebrospinal fluid on T2-weighted images.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Finnish elite cross-country skiers (national teams from the age of 16)

排除标准

  • 未提供

结局指标

主要结局

Low back pain (LBP)

时间窗: Baseline

Low back pain NRS (numeric rating scale) 0 to 10, where 0 is the best value and 100 is the worst value.

Pfirrmann summary score

时间窗: Baseline

Summary score of individual Pfirrmann grades of lumbar discs (L1-L5). Grade is 5 to 25, where 5 is the best value and 25 the worst value.

次要结局

  • Oswestry Disability Index (ODI)(Baseline)
  • EQ-5D-5L(Baseline)

研究者

发起方
Orton Orthopaedic Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验