Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04133818
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of a One-day-and-a-half for Patients With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '3 months', 'description': 'Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability)'}], 'secondaryOutcomes': [{'measure': 'Efficiency', 'timeFrame': '3 months', 'description': 'Efficiency of the program to diminish pain (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the most important pain and 0 no pain at all)'}, {'measure': 'Efficiency', 'timeFrame': '3 months', 'description': 'Efficiency of the program to diminish fear and beliefs (FABQ, between 0 and 66 with 66 representing the highest level of fear and beliefs about low back pain and 0 representing no fear and beliefs about low back pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multidisciplinary education and exercise therapy program.', 'Physical activity', 'Rehabilitation'], 'conditions': ['Subacute or Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '19204216', 'type': 'BACKGROUND', 'citation': 'Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.'}, {'pmid': '29229056', 'type': 'BACKGROUND', 'citation': 'Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.'}, {'pmid': '18024224', 'type': 'BACKGROUND', 'citation': 'Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. doi: 10.1016/j.spinee.2007.07.389. Epub 2007 Nov 19.'}, {'pmid': '31158552', 'type': 'BACKGROUND', 'citation': 'Garofoli R, Boisson M, Segretin F, Linieres J, Gerard C, Moreau S, Ieong E, Chagny F, Bedin C, Lefevre-Colau MM, Rannou F, Roren A, Nguyen C. Feasibility of a short multidisciplinary education and exercise therapy program for patients with non-specific low back pain: A 3-month retrospective open pilot study. Ann Phys Rehabil Med. 2019 Sep;62(5):382-385. doi: 10.1016/j.rehab.2019.05.005. Epub 2019 May 31. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the feasibility of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program in the subgroup of patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.', 'detailedDescription': "Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.\n\nThis no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.\n\nIt is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.\n\nData regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated and who had benefited in PMR unit of Cochin' hospital of a no intensive multidisciplinary rehabilitation program.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* subacute or chronic non-specific LBP ≥ 6 weeks\n* no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP\n* currently working\n* written consent\n\nExclusion Criteria:\n\n* inability to speak or read French\n* cognitive impairment\n* current sick leave\n* history of intensive multidisciplinary rehabilitation program for LBP'}, 'identificationModule': {'nctId': 'NCT04133818', 'acronym': 'LC-ONE', 'briefTitle': 'Feasibility of a One-day-and-a-half for Patients With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study', 'orgStudyIdInfo': {'id': 'LC-ONE'}, 'secondaryIdInfos': [{'id': 'APHP190887', 'type': 'OTHER', 'domain': 'APHP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multidisciplinary program.', 'description': 'Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.', 'interventionNames': ['Behavioral: Multidisciplinary education and exercise therapy program']}], 'interventions': [{'name': 'Multidisciplinary education and exercise therapy program', 'type': 'BEHAVIORAL', 'description': 'Multidisciplinary program: one and a half day of education and exercise therapy about low back pain :\n\n* Lectures and explanations about low back pain\n* Physical activity\n* Relaxation', 'armGroupLabels': ['Multidisciplinary program.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Christelle NGUYEN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHP (Assistance Publique-Hôpitaux de Paris)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}