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

October 31, 2023 updated by: Orton Orthopaedic Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • In The USA Or Canada, Please Select...
      • Helsinki, In The USA Or Canada, Please Select..., Finland, 02800
        • Research Institute Orton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All skiers who are selected to the national teams at season 2022-2023.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Baseline
Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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