Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-26 @ 2:54 PM
Study NCT ID:
NCT00924495
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2009-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-10', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between cortical activity and other motor control tests', 'timeFrame': 'day 1 and day 19'}], 'secondaryOutcomes': [{'measure': 'The effect of rTMS-therapy for clinical outcome and motor control tests', 'timeFrame': 'day 19, 1 month, 2 months, 1 year'}]}, 'conditionsModule': {'keywords': ['low back pain', 'motor control', 'cortical regulation', 'transcranial magnetic stimulation'], 'conditions': ['Chronic Nonspecific Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic nonspecific low back pain for at least six months\n* male gender\n* age 25-50 yrs\n* average pain during last week 4-8/10 by VAS\n* Oswestry disability index 20-80 %\n\nExclusion Criteria:\n\n* former spinal operations\n* rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs'}, 'identificationModule': {'nctId': 'NCT00924495', 'briefTitle': 'Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction', 'orgStudyIdInfo': {'id': 'KUH5960429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cortical function', 'description': 'Activity/inhibition of the cortex', 'interventionNames': ['Device: transcranial magnetic stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cortical regulation', 'interventionNames': ['Device: transcranial magnetic stimulation']}], 'interventions': [{'name': 'transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'rTMS therapy daily for two weeks, five times per week each lasting for half an hour', 'armGroupLabels': ['Cortical function', 'Cortical regulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Marja T Kilpiäinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Markku Kankaanpää, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Olavi Airaksinen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Timo Miettinen, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Hospital'}, {'name': 'Eeva Leino, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD Ass Proff, Head of the Department of Rehabilitation', 'investigatorFullName': 'olavi airaksinen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}