Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT01780194
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 666}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': '2 years'}]}, 'conditionsModule': {'conditions': ['Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment']}, 'referencesModule': {'references': [{'pmid': '23820296', 'type': 'DERIVED', 'citation': 'Saltychev M, Eskola M, Laimi K. Lumbar fusion compared with conservative treatment in patients with chronic low back pain: a meta-analysis. Int J Rehabil Res. 2014 Mar;37(1):2-8. doi: 10.1097/MRR.0b013e328363ba4b.'}]}, 'descriptionModule': {'briefSummary': '* To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain.\n* Meta-analysis using fixed effect model synthesis method.\n* Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People with chronic low back pain due to degenerative spinal conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* controlled randomized or non-randomized studies\n\nExclusion Criteria:\n\n* not specified'}, 'identificationModule': {'nctId': 'NCT01780194', 'briefTitle': 'Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'orgStudyIdInfo': {'id': 'FUSION_META_TYH_2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar fusion group'}, {'label': 'Conservative treatment group'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mikhail Saltychev, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}