Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT03763994
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reliability of measurement tool', 'timeFrame': 'February 2012-February 2013', 'description': 'reliability of measurement tool'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Reliability, Validity of Measurement to Assess Lumbar Spine Motion', 'Comparison of Healthy Subjects and Low Back Pain Patients']}, 'descriptionModule': {'briefSummary': 'Main of the study is to assess the reliability of a new objective tool to measure lumbar spine motion. The data will be collected from healthy subjects and subjects with frequent or daily low back pain in the last three months. In addition we compare the results of the motion measurements with disability and pain questionnaires such as the Roland Morris, Oswestry Disability Index and the Brief Pain Inventory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Low back pain patients were recruited among in-and outpatients of the Department of Pain Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by distributing flyers in sport groups and among hospital staff and friends.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years, informed consent, sufficient German skills \\<30 days low back pain in the last 90 days (control group) \\>31days of low back pain in the last 90 days (low back pain group)\n\nExclusion Criteria:\n\n* neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease), Current pain \\>= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery (control group), inability to perform choreography (LBP group)'}, 'identificationModule': {'nctId': 'NCT03763994', 'briefTitle': 'Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients', 'orgStudyIdInfo': {'id': '4385-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group 1', 'description': 'Never low back pain in the last 3 months'}, {'label': 'Control group 2', 'description': 'occasionally (1-30days) low back pain in the last 3 months'}, {'label': 'Low back pain group 3', 'description': 'frequently (31-60days) low back pain in the last 3 months'}, {'label': 'Low back pain group 4', 'description': 'daily (61-90days) low back pain in the last 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44789', 'city': 'Bochum', 'state': 'Northrine-Westfalia', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliches Universitätklinikum Bergmannsheil', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Christoph Maier, Pain Medicine', 'investigatorFullName': 'Christoph Maier, Prof. Dr.', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}