Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 1:27 PM
Study NCT ID:
NCT05200533
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2022-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Task-sharing and Shifting Model for Acute 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059825', 'term': 'Physical Therapists'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Data analysis will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 195}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-26', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Effect of the TS/S model on acute low back pain (LBP) patients' disability at 6 weeks", 'timeFrame': '6 weeks after the initial consultation', 'description': 'Rolland Morris Disability Questionnaire It is a 24 points scale. The lower score is 0, the higher score is 24. Higher scores mean worse outcomes as the disability level is higher.'}], 'secondaryOutcomes': [{'measure': "Effect of the TS/S model on acute LBP patients' disability at 3 months", 'timeFrame': '3 months after the initial consultation', 'description': 'Rolland Morris Disability Questionnaire It is a 24 points scale. Scores rank form 0 to 24. Higher scores mean worse outcomes as the disability level is higher.'}, {'measure': "Effect of the TS/S model on acute LBP patient's pain at 6 weeks and 3 months", 'timeFrame': '6 weeks and 3 months after the initial consultation', 'description': 'Brief Pain Inventory It is a 10 points scale. Scores rank from 0 to 10. Higher scores mean worse outcomes, as the pain level is higher.'}, {'measure': "Effect of the TS/S model on acute LBP patient's psychosocial risk factors at 6 weeks and 3 months", 'timeFrame': '6 weeks and 3 months after the initial consultation', 'description': 'Start-Back screening tool It is a 9 points scale. Scores rank from 0 to 9. Higher scores mean worse outcomes.'}, {'measure': "Effect of the TS/S model on acute LBP patient's satisfaction", 'timeFrame': 'Few minutes after the initial consultation (less than one hour)', 'description': 'Medrisk questionnaire It is a 5 points scale. Scores rank from 0 to 5. Higher scores mean better outcomes;'}, {'measure': "Effect of the TS/S model on acute LBP patient's wait time before the initial consultation", 'timeFrame': 'Initial consultation', 'description': 'Time (number of days and hours)'}, {'measure': 'Effect of the TS/S model on healthcare resources use', 'timeFrame': 'Initial consultation, 6 weeks and 3 months after the initial consultation', 'description': 'Initial prescription of sick leave and medications, number of family physician visits, number of physical therapy appointments, number of emergency department visits at 6 weeks and 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Task-sharing', 'Task-shifting', 'Family physician', 'Physiotherapist'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '32628696', 'type': 'BACKGROUND', 'citation': 'Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020.'}, {'pmid': '31603709', 'type': 'BACKGROUND', 'citation': 'Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.'}, {'pmid': '27081203', 'type': 'BACKGROUND', 'citation': 'Chiarotto A, Maxwell LJ, Terwee CB, Wells GA, Tugwell P, Ostelo RW. Roland-Morris Disability Questionnaire and Oswestry Disability Index: Which Has Better Measurement Properties for Measuring Physical Functioning in Nonspecific Low Back Pain? Systematic Review and Meta-Analysis. Phys Ther. 2016 Oct;96(10):1620-1637. doi: 10.2522/ptj.20150420. Epub 2016 Apr 14.'}, {'pmid': '22716771', 'type': 'BACKGROUND', 'citation': 'Desmeules F, Roy JS, MacDermid JC, Champagne F, Hinse O, Woodhouse LJ. Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review. BMC Musculoskelet Disord. 2012 Jun 21;13:107. doi: 10.1186/1471-2474-13-107.'}, {'pmid': '21963002', 'type': 'BACKGROUND', 'citation': 'Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.'}, {'pmid': '34928239', 'type': 'BACKGROUND', 'citation': 'Kechichian A, Lafrance S, Matifat E, Dube F, Lussier D, Benhaim P, Perreault K, Filiatrault J, Rainville P, Higgins J, Rousseau J, Masse J, Desmeules F. Multimodal Interventions Including Rehabilitation Exercise for Older Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-analyses of Randomized Controlled Trials. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):34-49. doi: 10.1519/JPT.0000000000000279.'}, {'pmid': '39558330', 'type': 'DERIVED', 'citation': 'Kechichian A, Desmeules F, Girard P, Terrisse H, Vermorel C, Pinsault N. Physiotherapists as first-contact practitioners for patients with low back pain in French primary care: a pragmatic cluster randomised controlled trial. BMC Health Serv Res. 2024 Nov 18;24(1):1427. doi: 10.1186/s12913-024-11814-2.'}]}, 'descriptionModule': {'briefSummary': "Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction.\n\nDesign: Pragmatic cluster randomized controlled trial"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 20 to 55 years old\n* Suffering from acute low back pain since less than 4 weeks\n* Able to understand and speak French\n* Whose family physician is included in the task-sharing and shifting model (only in the intervention group)\n\nExclusion Criteria:\n\n* Protected patient according to the public health regulation,\n* Patient unable to fill the survey,\n* Non-availability of the physiotherapist to receive the patient (only in the intervention group)'}, 'identificationModule': {'nctId': 'NCT05200533', 'acronym': 'LombalgIP', 'briefTitle': 'Task-sharing and Shifting Model for Acute Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Task-sharing and Shifting Model Between Family Physicians and Physiotherapists for Acute Low Back Pain Patients: a Pragmatic Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '38RC21.0259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Task-sharing and shifting', 'description': 'In the task-sharing and shifting group, family physicians shifted acute low back pain consultations to physiotherapists. Patients with acute low back pain are seen by the physiotherapist instead of family physician. Physiotherapist diagnose acute low back pain, identify red and yellow flags, prescribe sick leave and medications and can refer the patient to additional physical therapy treatment.', 'interventionNames': ['Other: Task-sharing and shifting model between family physicians and physiotherapists']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'In the usual care group, patients with acute low back pain are seen by their family physician.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Task-sharing and shifting model between family physicians and physiotherapists', 'type': 'OTHER', 'description': 'Medical consultations for acute low back pain patients are shifted from family physicians to physiotherapists.', 'armGroupLabels': ['Task-sharing and shifting']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Medical consultations for acute low back pain patients are performed by family physicians', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74960', 'city': 'Annecy', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Céline Tuttino', 'role': 'CONTACT', 'email': 'medicran74@gmail.com'}, {'name': 'Bruno Mas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de santé pluriprofessionnelle de Cran Gévrier', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '73000', 'city': 'Chambéry', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Fuentes', 'role': 'CONTACT', 'email': 'emilie.f@recoords.fr'}, {'name': 'Guillaume Bouchet, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de santé pluriprofessionnelle des Hauts de Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '38500', 'city': 'Coublevie', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabine Pages', 'role': 'CONTACT', 'email': 'sabine.pages@free.fr'}, {'name': 'Patrick Lambert, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de santé pluriprofessionnelle de Voiron-Sud', 'geoPoint': {'lat': 45.35856, 'lon': 5.61146}}, {'zip': '38250', 'city': 'Lans-en-Vercors', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia Wrona', 'role': 'CONTACT', 'email': 'assistanteencoordination@gmail.com'}, {'name': 'Alban Thoret', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de santé pluriprofessionnelle de Lans-en-Vercors - Pôle Santé en Vercors', 'geoPoint': {'lat': 45.12852, 'lon': 5.58599}}, {'zip': '38430', 'city': 'Moirans', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabine Pages', 'role': 'CONTACT', 'email': 'sabine.pages@free.fr'}, {'name': 'Muriel Carlotti, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maison de santé pluriprofessionnelle de Moirans', 'geoPoint': {'lat': 45.3314, 'lon': 5.55432}}, {'zip': '38400', 'city': "Saint-Martin-d'Hères", 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maxime Bertolini', 'role': 'CONTACT', 'email': 'maxime.bertolini@psip-smh.fr'}, {'name': 'Laura Vasselier', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Pôle de santé interprofessionnel de Saint-Martin d'Hères", 'geoPoint': {'lat': 45.1787, 'lon': 5.76281}}], 'centralContacts': [{'name': 'Amelie Kechichian, PhD student', 'role': 'CONTACT', 'email': 'akechichian@chu-grenoble.fr', 'phone': '+33 (0)698304997'}, {'name': 'Aida Mandzo', 'role': 'CONTACT', 'email': 'amandzo@chu-grenoble.fr', 'phone': '+33(0)476766816'}], 'overallOfficials': [{'name': 'Nicolas Pinsault, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Grenoble Alps'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}