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OpenTrials
Completed

NCT Number: NCT05641857

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

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.

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Key information

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute Orton

Helsinki, In the USA Or Canada, Please Select..., 02800, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Pfirrmann summary score

    Time frame: 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.

  2. Low back pain (LBP)

    Time frame: Baseline

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

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Baseline

    Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.

  2. EQ-5D-5L

    Time frame: Baseline

    The health-related quality of life, 0 to 100, where 0 is the worst value and 100 the best value.

Sponsors and collaborators

Lead sponsor

Orton Orthopaedic Hospital

Other

Collaborators

  • Helsinki University Central Hospital
  • Päijät Häme Central Hospital
  • University of Helsinki

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2022
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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