- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641857
Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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In The USA Or Canada, Please Select...
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Helsinki, In The USA Or Canada, Please Select..., Finland, 02800
- Research Institute Orton
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Finnish elite cross-country skiers (national teams from the age of 16)
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Low back pain and disc degeneration among elite cross-country skiers
No intervention Interview, clinical examination and MRI
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Low back pain and disc degeneration among healthy volunteers
No intervention Interview, clinical examination and MRI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pfirrmann summary score
Time Frame: Baseline
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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.
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Baseline
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Low back pain (LBP)
Time Frame: Baseline
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Low back pain NRS (numeric rating scale) 0 to 10, where 0 is the best value and 100 is the worst value.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oswestry Disability Index (ODI)
Time Frame: Baseline
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Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.
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Baseline
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EQ-5D-5L
Time Frame: Baseline
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The health-related quality of life, 0 to 100, where 0 is the worst value and 100 the best value.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Teija Lund, Helsinki University Hospital and Helsinki University
- Principal Investigator: Anni Aavikko, PHHYKY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 465 (BMT CTN)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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