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

Sponsor
Orton Orthopaedic Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05641857
Collaborator
Helsinki University Hospital and Helsinki University (Other), Päijät-Häme Central Hospital (Other)
100
1
8.9
11.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    May 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Low back pain and disc degeneration among elite cross-country skiers

    No intervention Interview, clinical examination and MRI

    Low back pain and disc degeneration among healthy volunteers

    No intervention Interview, clinical examination and MRI

    Outcome Measures

    Primary Outcome Measures

    1. Pfirrmann summary score [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) [Baseline]

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

    Secondary Outcome Measures

    1. Oswestry Disability Index (ODI) [Baseline]

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

    2. EQ-5D-5L [Baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Finnish elite cross-country skiers (national teams from the age of 16)
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Institute Orton Helsinki In The USA Or Canada, Please Select... Finland 02800

    Sponsors and Collaborators

    • Orton Orthopaedic Hospital
    • Helsinki University Hospital and Helsinki University
    • Päijät-Häme Central Hospital

    Investigators

    • Study Director: Teija Lund, Helsinki University Hospital and Helsinki University
    • Principal Investigator: Anni Aavikko, PHHYKY

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Orton Orthopaedic Hospital
    ClinicalTrials.gov Identifier:
    NCT05641857
    Other Study ID Numbers:
    • 465
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Orton Orthopaedic Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 12, 2022