Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-01 @ 4:07 AM
Study NCT ID:
NCT05286333
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2022-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions
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': 'ESTIMATED', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-10', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of sick leaves induced by lower back pain', 'timeFrame': '3 months after the rehabilitation program', 'description': 'Number of sick leaves induced by lower back pain after the rehabilitation program'}, {'measure': 'Recurrence of sick leaves induced by lower back pain', 'timeFrame': '6 months after the rehabilitation program', 'description': 'Number of sick leaves induced by lower back pain after the rehabilitation program'}, {'measure': 'Recurrence of sick leaves induced by lower back pain', 'timeFrame': '9 months after the rehabilitation program', 'description': 'Number of sick leaves induced by lower back pain after the rehabilitation program'}, {'measure': 'Recurrence of sick leaves induced by lower back pain', 'timeFrame': '12 months after the rehabilitation program', 'description': 'Number of sick leaves induced by lower back pain after the rehabilitation program'}], 'secondaryOutcomes': [{'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (1)', 'timeFrame': 'Baseline', 'description': 'demography (sexe and age) will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (2)', 'timeFrame': 'Baseline', 'description': 'anthropometric data (weight, BMI) will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)', 'timeFrame': 'Baseline', 'description': 'quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (3)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'quality of life,evaluated by Oswestry scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)', 'timeFrame': 'Baseline', 'description': 'Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (4)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'Physiological state, evaluated by hospital anxiety and depression scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)', 'timeFrame': 'Baseline', 'description': 'physical activity, evaluated by Ricci \\& gagnon questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'physical activity, evaluated by Ricci \\& gagnon questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'physical activity, evaluated by Ricci \\& gagnon questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'physical activity, evaluated by Ricci \\& gagnon questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (5)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'physical activity, evaluated by Ricci \\& gagnon questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)', 'timeFrame': 'Baseline', 'description': 'Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (6)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'Pain, evaluated with a visual analog scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)', 'timeFrame': 'Baseline', 'description': 'Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (7)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'Impact of lower back pain on wellbeing, evaluated with Dallas questionnaire, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)', 'timeFrame': 'Baseline', 'description': 'stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (8)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'stress at work, evaluated with Karasek scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)', 'timeFrame': 'Baseline', 'description': 'Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)', 'timeFrame': '3 months after the rehabilitation program', 'description': 'Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)', 'timeFrame': '9 months after the rehabilitation program', 'description': 'Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (9)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'Fear and beliefs, evaluated with FABQ (Fear-avoidance beliefs questionnaire) scale, will be analysed as risk factor of recurrence'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)', 'timeFrame': 'Baseline', 'description': 'locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (10)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'locomotor capacity (flexibility and endurance) will be analysed as risk factor of recurrence.'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)', 'timeFrame': 'Baseline', 'description': 'neurological impact (tendon reflex) will be analysed as risk factor of recurrence.'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)', 'timeFrame': '6 months after the rehabilitation program', 'description': 'neurological impact (tendon reflex) will be analysed as risk factor of recurrence.'}, {'measure': 'Risk factor analysis of recurrence of sick leaves induced by lower back pain (11)', 'timeFrame': '12 months after the rehabilitation program', 'description': 'neurological impact (tendon reflex) will be analysed as risk factor of recurrence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '24595187', 'type': 'BACKGROUND', 'citation': 'Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.'}, {'pmid': '26516339', 'type': 'BACKGROUND', 'citation': 'Cougot B, Petit A, Paget C, Roedlich C, Fleury-Bahi G, Fouquet M, Menu P, Dubois C, Geraut C, Roquelaure Y, Tripodi D. Chronic low back pain among French healthcare workers and prognostic factors of return to work (RTW): a non-randomized controlled trial. J Occup Med Toxicol. 2015 Oct 29;10:40. doi: 10.1186/s12995-015-0082-5. eCollection 2015.'}, {'pmid': '6450426', 'type': 'BACKGROUND', 'citation': "Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available."}, {'pmid': '2524890', 'type': 'BACKGROUND', 'citation': 'Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007.'}, {'pmid': '31208917', 'type': 'BACKGROUND', 'citation': 'da Silva T, Mills K, Brown BT, Pocovi N, de Campos T, Maher C, Hancock MJ. Recurrence of low back pain is common: a prospective inception cohort study. J Physiother. 2019 Jul;65(3):159-165. doi: 10.1016/j.jphys.2019.04.010. Epub 2019 Jun 14.'}, {'pmid': '28355981', 'type': 'BACKGROUND', 'citation': 'da Silva T, Mills K, Brown BT, Herbert RD, Maher CG, Hancock MJ. Risk of Recurrence of Low Back Pain: A Systematic Review. J Orthop Sports Phys Ther. 2017 May;47(5):305-313. doi: 10.2519/jospt.2017.7415. Epub 2017 Mar 29.'}, {'pmid': '12184438', 'type': 'BACKGROUND', 'citation': 'Yvanes-Thomas M, Calmels P, Bethoux F, Richard A, Nayme P, Payre D, Laurent B. Validity of the French-language version of the Quebec back pain disability scale in low back pain patients in France. Joint Bone Spine. 2002 Jun;69(4):397-405. doi: 10.1016/s1297-319x(02)00415-3.'}, {'pmid': '3389427', 'type': 'BACKGROUND', 'citation': 'Karasek RA, Theorell T, Schwartz JE, Schnall PL, Pieper CF, Michela JL. Job characteristics in relation to the prevalence of myocardial infarction in the US Health Examination Survey (HES) and the Health and Nutrition Examination Survey (HANES). Am J Public Health. 1988 Aug;78(8):910-8. doi: 10.2105/ajph.78.8.910.'}, {'pmid': '8455963', 'type': 'BACKGROUND', 'citation': 'Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.'}, {'pmid': '15082995', 'type': 'BACKGROUND', 'citation': 'Chaory K, Fayad F, Rannou F, Lefevre-Colau MM, Fermanian J, Revel M, Poiraudeau S. Validation of the French version of the fear avoidance belief questionnaire. Spine (Phila Pa 1976). 2004 Apr 15;29(8):908-13. doi: 10.1097/00007632-200404150-00018.'}]}, 'descriptionModule': {'briefSummary': 'Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33 % rate of recurrence during the first year, converting LBP into a chronic condition.\n\nThe french High healthy authority recommend early occupational oriented intervention associated with a multidisciplinary rehabilitation program.\n\nHowever even if these recommendations are taken into appropriate account, risk for recurrence of Low back pain and occupational repercussions often occured.\n\nThis study aims to identify the risk factor(s) of sick leave after a rehabilitation stay in outpatients and thus adapt cares provided to the patients in respect of their needs and expectations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the beneficiaries of the multidisciplinary follow-up shared between the physical and rehabilitation medicine and occupational medicine, will be elligible in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women over 18 years old\n* able to understand and respect the protocol requirement\n* who signed the consent prior to any other procedure protocol\n* patients suffering from chronic lower back or lumbo-radicular pain since more than 3 months\n* employee bellow 3 years before retirement\n* patients included in a multidisciplinary rehabilitation program and occupational medicine\n\nExclusion Criteria:\n\n* major patients under guardianship/curator/legal protection\n* pregnant patients\n* obese patients with BMI (body mass index) \\> 35 (grade 2)\n* patients suffering from neurological pathology\n* patients suffering from chronic lower back or lumbo-radicular pain since less than 3 months\n* patients suffering from chronic lower back pain with inflammatory or tumoral or infectious ethiology'}, 'identificationModule': {'nctId': 'NCT05286333', 'acronym': 'LORET', 'briefTitle': 'Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Ildys'}, 'officialTitle': 'Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions Among Beneficiaries of a Multidisciplinary Follow-up Shared Between Physical and Rehabilitation Medicine and Occupational Medicine: a Monocentric Prospective Study', 'orgStudyIdInfo': {'id': 'ID-RCB 2021-A02371-40'}}, 'contactsLocationsModule': {'locations': [{'city': 'Roscoff', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jocelyne PENGAM', 'role': 'CONTACT', 'email': 'jocelyne.pengam@ildys.org'}, {'name': 'Morgane AUFFRET', 'role': 'CONTACT', 'email': 'morgane.auffret@ildys.org'}, {'name': 'Jen-Sebastien BOURSEUL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marieke DAVION, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier HA, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre de Perharidy', 'geoPoint': {'lat': 48.72381, 'lon': -3.98709}}], 'centralContacts': [{'name': 'Marion Buyse, PharmD, PhD', 'role': 'CONTACT', 'email': 'marion.buyse@ildys.org', 'phone': '0298293447'}, {'name': 'Matthieu Pichelin', 'role': 'CONTACT', 'email': 'matthieu.pichelin@ildys.org'}], 'overallOfficials': [{'name': 'Jean-Sébastien Bourseul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ildys'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ildys', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lille Catholic University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}