Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 10:39 PM
Study NCT ID:
NCT02612467
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2015-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Back Pain - What's Next? Stratified Care Compared to Current Practice
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-20', 'lastUpdatePostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported change measured by the Roland Morris Disability Questionnaire', 'timeFrame': '3 and 12 months', 'description': 'Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire', 'timeFrame': '12 months', 'description': 'The health economic analysis will test the cost-effectiveness/cost-utility of SBT against current practice. Patient reported quality of life on the EuroQol (EQ-5D) questionnaire'}, {'measure': 'Change in pain intensity measured on a numeric range scale', 'timeFrame': '3 and 12 months', 'description': 'Change in pain intensity is monitored on numeric range scales indicating back and leg pain.'}, {'measure': 'Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)', 'timeFrame': '3 and 12 months', 'description': 'Short and long term time of work is monitored by standardized data from the Danish National Register on Public Transfer Payments (DREAM)'}, {'measure': 'Time off work monitored by standardized patient reported data', 'timeFrame': '3 and 12 months', 'description': 'Short and long term time of work is monitored by standardized patient reported data'}, {'measure': 'Patient reported global change measured by the questionnaire "Global Impression of Change"', 'timeFrame': '3 and 12 months', 'description': 'Patients perception of global change is monitored by the questionnaire "Global Impression of Change"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['start back tool', 'stratified care', 'targeted treatment'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '21769444', 'type': 'BACKGROUND', 'citation': 'Morso L, Albert H, Kent P, Manniche C, Hill J. Translation and discriminative validation of the STarT Back Screening Tool into Danish. Eur Spine J. 2011 Dec;20(12):2166-73. doi: 10.1007/s00586-011-1911-6. Epub 2011 Jul 19.'}, {'pmid': '21963002', 'type': 'RESULT', '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': '34101953', 'type': 'DERIVED', 'citation': 'Morso L, Olsen Rose K, Schiottz-Christensen B, Sowden G, Sondergaard J, Christiansen DH. Effectiveness of stratified treatment for back pain in Danish primary care: A randomized controlled trial. Eur J Pain. 2021 Oct;25(9):2020-2038. doi: 10.1002/ejp.1818. Epub 2021 Jul 2.'}, {'pmid': '29884217', 'type': 'DERIVED', 'citation': 'Morso L, Schiottz-Christensen B, Sondergaard J, Andersen NV, Pedersen F, Olsen KR, Jensen MS, Hill J, Christiansen DH. The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial. Trials. 2018 Jun 8;19(1):315. doi: 10.1186/s13063-018-2685-5.'}], 'seeAlsoLinks': [{'url': 'http://www.keele.ac.uk/sbst/', 'label': 'Information regarding STarT Back Tool on the Keele University Homepage'}]}, 'descriptionModule': {'briefSummary': 'Background Studies in the United Kingdom find the stratified care model of the STarT Back Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients. However, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services.\n\nObjective To investigate the effectiveness of the stratified care model of the SBT, when embedded into the regional disease management programs on LBP in primary care as compared to current best practice care.', 'detailedDescription': 'Methods The study is a two-armed randomized controlled trial in Danish primary health care setting. In total 700 patients are included in the study.\n\nThe patients are randomised automatically by a developed database to; 1) Stratified care (treatment matched to stratification according to SBT) or 2) Control treatment (treatment based solely on clinical reasoning).\n\nAll data including patient consent is collected and monitored using a web-based data management system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients found eligible for referral to physiotherapy by the general practitioner (GP)\n* 18 years and above\n* understand Danish language.\n\nExclusion Criteria:\n\n* Serious pathology (malignancy, inflammatory arthritis, etc.),\n* serious nerve root compression (cauda equina, paresis \\<3),\n* influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.'}, 'identificationModule': {'nctId': 'NCT02612467', 'briefTitle': "Low Back Pain - What's Next? Stratified Care Compared to Current Practice", 'organization': {'class': 'OTHER', 'fullName': 'Region of Southern Denmark'}, 'officialTitle': 'The Effectiveness of a Stratified Care Model for Non-specific Low Back Pain in Danish Primary Care Compared to Current Practice in a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'S-20140205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratified care', 'description': 'Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group', 'interventionNames': ['Other: Stratified care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Current care', 'description': 'Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.', 'interventionNames': ['Other: Current care']}], 'interventions': [{'name': 'Stratified care', 'type': 'OTHER', 'description': 'Patients are stratified according to the SBT subgroups (low, medium and high risk) and the appropriate matched intervention will be delivered accordingly.\n\nLow risk: Reassuring information. Onwards referral, investigation or further treatment is not recommended Medium risk: In addition to reassuring information patients receive evidence based individualised treatment focusing on restoring function (targeting back pain, leg pain, co-morbid pain and disability) High risk : In addition to medium risk treatment patients will receive individualised psychologically informed physiotherapy aiming to reduce pain and disability.', 'armGroupLabels': ['Stratified care']}, {'name': 'Current care', 'type': 'OTHER', 'description': 'Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.', 'armGroupLabels': ['Current care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'state': 'Central Region', 'country': 'Denmark', 'facility': 'Department of Occ. Medicine', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '5500', 'city': 'Middelfart', 'state': 'Southern Denmark', 'country': 'Denmark', 'facility': 'Centre for Quality', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}], 'overallOfficials': [{'name': 'Lars Morsø, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Quality, Institute for Regional Healthresearch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herning Hospital', 'class': 'OTHER'}, {'name': 'Research Unit of General Practice, Odense', 'class': 'OTHER'}, {'name': 'Spine Centre of Southern Denmark', 'class': 'OTHER'}, {'name': 'Keele University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Lars Morsoe', 'investigatorAffiliation': 'Region of Southern Denmark'}}}}