Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT02466360
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2015-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-08', 'studyFirstSubmitDate': '2015-06-05', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual interviews', 'timeFrame': 'at day 1', 'description': 'patients with non-specific chronic lower back pain explain directly to their doctors what is preventing them from having physical activity'}], 'secondaryOutcomes': [{'measure': 'questions about their lower back pain and physical activity', 'timeFrame': 'at day 1'}, {'measure': 'Back Belief questionnaire', 'timeFrame': 'at day 1', 'description': "\\- Back Belief questionnaire that evaluates patients' knowledge about lower back pain"}, {'measure': 'QUEBEC scale', 'timeFrame': 'at day 1', 'description': '\\- QUEBEC scale that evaluates the impact of lower back pain on the daily lives of patients'}, {'measure': 'Fear Avoidance Beliefs questionnaire', 'timeFrame': 'at day 1', 'description': '\\- Fear Avoidance Beliefs questionnaire that evaluates fears and beliefs about the disease'}, {'measure': 'Visual Analog Scale', 'timeFrame': 'at day 1', 'description': 'Visual Analog Scale that evaluates pain'}]}, 'conditionsModule': {'keywords': ['Non-specific chronic lower back pain', 'Physical activity', 'Self-exercises', 'Brakes', 'Levers', 'Adhesion', 'Self-care'], 'conditions': ['Non-specific Chronic Lower Back Pain']}, 'descriptionModule': {'briefSummary': 'Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.\n\nPhysical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.\n\nThe aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.', 'detailedDescription': 'Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.\n\nPhysical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.\n\nThe aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic lower back pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female who are at least 18 years old\n* Patients with non-specific chronic lower back pain\n\nExclusion Criteria:\n\n* Mental or physical disabilities incompatible with focus groups/individual interviews and filling out questionnaires.\n* Inability to understand or speak French properly\n* Symptomatic lower back pain'}, 'identificationModule': {'nctId': 'NCT02466360', 'briefTitle': 'What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain : a Qualitative Study', 'orgStudyIdInfo': {'id': 'CHU-0237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic lower back pain', 'interventionNames': ['Behavioral: Back Belief questionnaire', 'Behavioral: QUEBEC scale', 'Behavioral: Fear Avoidance beliefs questionnaire', 'Behavioral: Visual analog scale', 'Behavioral: individual interviews', 'Behavioral: Focus groups']}], 'interventions': [{'name': 'Back Belief questionnaire', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}, {'name': 'QUEBEC scale', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}, {'name': 'Fear Avoidance beliefs questionnaire', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}, {'name': 'Visual analog scale', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}, {'name': 'individual interviews', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}, {'name': 'Focus groups', 'type': 'BEHAVIORAL', 'armGroupLabels': ['chronic lower back pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Emmanuel COUDEYRE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}