Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-04-20 @ 3:58 PM
Study NCT ID:
NCT02226692
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2014-08-12', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability level', 'timeFrame': '2 months', 'description': 'Oswestry disability index'}, {'measure': 'Disability level', 'timeFrame': '4 months', 'description': 'Oswestry disability index'}, {'measure': 'Disability level', 'timeFrame': '6 months', 'description': 'Oswestry disability index'}, {'measure': 'Disability level', 'timeFrame': '12 months', 'description': 'Oswestry disability index'}], 'secondaryOutcomes': [{'measure': 'Pain intensity in the past 2 months', 'timeFrame': '2 months', 'description': '101 points numerical rating scale'}, {'measure': 'Fear of movement level', 'timeFrame': '2 months', 'description': 'Tampa scale for kinesiophobia'}, {'measure': "Patient's global impression of change from baseline", 'timeFrame': '6 months', 'description': "Patient's global impression of change scale"}, {'measure': "Patient's global impression of change from 6 months", 'timeFrame': '12 months', 'description': "Patient's global impression of change scale"}, {'measure': 'Pain intensity in the past 2 months', 'timeFrame': '4 months', 'description': '101 points numerical rating scale'}, {'measure': 'Pain intensity in the past 2 months', 'timeFrame': '6 months', 'description': '101 points numerical rating scale'}, {'measure': 'Pain intensity in the past 6 months', 'timeFrame': '12 months', 'description': '101 points numerical rating scale'}, {'measure': 'Pain intensity in the past week', 'timeFrame': '12 months', 'description': '101 points numerical rating scale'}, {'measure': 'Fear of movement level', 'timeFrame': '4 months', 'description': 'Tampa scale for kinesiophobia'}, {'measure': 'Fear of movement level', 'timeFrame': '6 months', 'description': 'Tampa scale for kinesiophobia'}, {'measure': 'Fear of movement level', 'timeFrame': '12 months', 'description': 'Tampa scale for kinesiophobia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic low back pain', 'prognostic factors', 'disabling low back pain', 'lumbar muscle activity', 'start back screening tool', 'physical evaluation'], 'conditions': ['Chronic Low Back Pain', 'Mechanical Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '26286385', 'type': 'DERIVED', 'citation': 'Page I, Abboud J, O Shaughnessy J, Laurencelle L, Descarreaux M. Chronic low back pain clinical outcomes present higher associations with the STarT Back Screening Tool than with physiologic measures: a 12-month cohort study. BMC Musculoskelet Disord. 2015 Aug 19;16:201. doi: 10.1186/s12891-015-0669-0.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. It has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "volunteer with chronic nonspecific low back pain will be recruited among the university's community, its outpatients' chiropractic clinic and through advertisements in the local newspaper. They will first be screened by clinicians at the outpatients' chiropractic clinic in order to assess for the various inclusion and exclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults between 18 and 60 years old\n* nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified\n* chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain\n* able to read and understand French\n\nExclusion Criteria:\n\n* History of surgery or major trauma to the spine\n* Current use of medication known to impair physical effort and pain perception\n* Lumbar scoliosis of more than 20°\n* Collagenosis, severe osteoporosis\n* Neuromuscular disease\n* Malignant tumor\n* Non-controlled hypertension\n* Infection\n* Radiculopathy\n* Progressive neurologic defect\n* Myelopathy\n* Lumbar disc hernia\n* Pregnancy\n* Active lower body injury and/or severe and disabling pain limiting the capacity to undergo the evaluation.'}, 'identificationModule': {'nctId': 'NCT02226692', 'briefTitle': 'Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Université du Québec à Trois-Rivières'}, 'officialTitle': 'Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study', 'orgStudyIdInfo': {'id': 'UQTR-2011-PFAC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nonspecific chronic low back pain', 'description': 'Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G9A 5H7', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université du Québec à Trois-Rivières', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], 'overallOfficials': [{'name': 'Martin Descarreaux, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université du Québec à Trois-Rivières'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université du Québec à Trois-Rivières', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Martin Descarreaux DC, PhD', 'investigatorFullName': 'Martin Descarreaux', 'investigatorAffiliation': 'Université du Québec à Trois-Rivières'}}}}