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

Disc Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641857
• Other study ID #: 465
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Orton Orthopaedic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Back Pain
• Disc Degeneration
• Intervertebral Disc Degeneration
• Low Back Pain

Locations

Country	Name	City	State
Finland	Research Institute Orton	Helsinki	In The USA Or Canada, Please Select...

Sponsors (4)

Lead Sponsor	Collaborator
Orton Orthopaedic Hospital	Helsinki University Central Hospital, Päijät Häme Central Hospital, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Baseline
Secondary	Oswestry Disability Index (ODI)	Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.	Baseline
Secondary	EQ-5D-5L	The health-related quality of life, 0 to 100, where 0 is the worst value and 100 the best value.	Baseline