Disc DegenerationNCT05641857
Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
An observational study of Disc Degeneration, run by Orton Orthopaedic Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Disc Degeneration
- How many people
- 63 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All skiers who are selected to the national teams at season 2022-2023.
Who may be able to join
- Finnish elite cross-country skiers (national teams from the age of 16)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Finland1 site
Research Institute Orton
Helsinki, In the USA Or Canada, Please Select..., 02800
About this study
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.
Read the 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.
- Conditions
- Disc Degeneration
- Keywords
- low back pain, disc degeneration, athlete, matched case control
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pfirrmann summary score
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.
Measured: Baseline
Low back pain (LBP)
Low back pain NRS (numeric rating scale) 0 to 10, where 0 is the best value and 100 is the worst value.
Measured: Baseline
Secondary outcomes (2)
Oswestry Disability Index (ODI)
Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.
Measured: Baseline
EQ-5D-5L
The health-related quality of life, 0 to 100, where 0 is the worst value and 100 the best value.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orton Orthopaedic Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, Päijät Häme Central Hospital
- Responsible party
- Sponsor
- Investigators
- Teija Lund, Study director, Helsinki University Hospital and Helsinki UniversityAnni Aavikko, Principal investigator, PHHYKY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641857
- Sponsor's protocol ID
- 465
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aavikko A, Pesonen J, Ristolainen L, Murto N, Kautiainen H, Lund T. Prevalence of Low Back Pain and Disc Degeneration in Elite Cross-Country Skiers: A Comparative Study With Non-Athlete Controls. Scand J Med Sci Sports. 2025 Dec;35(12):e70187. doi: 10.1111/sms.70187.
PubMed 41416933
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
- ClinicalTrials.gov ID
- NCT05641857
- Acronym / sponsor ID
- 465
- Conditions
- Disc Degeneration
- Keywords
- low back pain, disc degeneration, athlete, matched case control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Orton Orthopaedic HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, Päijät Häme Central Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All skiers who are selected to the national teams at season 2022-2023.
Key inclusion criteria (1 listed)
- Finnish elite cross-country skiers (national teams from the age of 16)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline
EQ-5D-5L
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 41416933Aavikko A, Pesonen J, Ristolainen L, Murto N, Kautiainen H, Lund T. Prevalence of Low Back Pain and Disc Degeneration in Elite Cross-Country Skiers: A Comparative Study With Non-Athlete Controls. Scand J Med Sci Sports. 2025 Dec;35(12):e70187. doi: 10.1111/sms.70187.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teija Lund study director
Helsinki University Hospital and Helsinki University
Anni Aavikko principal investigator
PHHYKY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Degeneration, run by Orton Orthopaedic Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pfirrmann summary score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.