Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-04-13 @ 6:58 PM
Study NCT ID:
NCT05641857
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2022-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pfirrmann summary score', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Low back pain (LBP)', 'timeFrame': 'Baseline', 'description': 'Low back pain NRS (numeric rating scale) 0 to 10, where 0 is the best value and 100 is the worst value.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline', 'description': 'Oswestry Disability Index, 0 to 100, where 0 is the best value and 100 the worst value.'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline', 'description': 'The health-related quality of life, 0 to 100, where 0 is the worst value and 100 the best value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low back pain', 'disc degeneration', 'athlete', 'matched case control'], 'conditions': ['Disc Degeneration']}, 'referencesModule': {'references': [{'pmid': '41416933', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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).\n\nBody 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.\n\nFrom 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All skiers who are selected to the national teams at season 2022-2023.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Finnish elite cross-country skiers (national teams from the age of 16)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05641857', 'briefTitle': 'Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers', 'organization': {'class': 'OTHER', 'fullName': 'Orton Orthopaedic Hospital'}, 'officialTitle': 'Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers', 'orgStudyIdInfo': {'id': '465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low back pain and disc degeneration among elite cross-country skiers', 'description': 'No intervention Interview, clinical examination and MRI'}, {'label': 'Low back pain and disc degeneration among healthy volunteers', 'description': 'No intervention Interview, clinical examination and MRI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02800', 'city': 'Helsinki', 'state': 'In the USA Or Canada, Please Select...', 'country': 'Finland', 'facility': 'Research Institute Orton', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Teija Lund', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Hospital and Helsinki University'}, {'name': 'Anni Aavikko', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PHHYKY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orton Orthopaedic Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'Päijät Häme Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}