Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 2:27 PM
Study NCT ID:
NCT00459433
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2007-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Right Intervention for the Right Patient
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2007-04-10', 'studyFirstSubmitQcDate': '2007-04-10', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days on sick leave and days with low back pain problems measured every week by SMS questionnaire', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': '12 months'}, {'measure': 'Activity of daily living', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Return to work', 'Biopsychosocial', 'Screening', 'SMS', 'Non specific low back pain'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '15082998', 'type': 'BACKGROUND', 'citation': 'Johansen B, Mainz J, Sabroe S, Manniche C, Leboeuf-Yde C. Quality improvement in an outpatient department for subacute low back pain patients: prospective surveillance by outcome and performance measures in a health technology assessment perspective. Spine (Phila Pa 1976). 2004 Apr 15;29(8):925-31. doi: 10.1097/00007632-200404150-00021.'}, {'pmid': '11790467', 'type': 'BACKGROUND', 'citation': 'Haldorsen EM, Grasdal AL, Skouen JS, Risa AE, Kronholm K, Ursin H. Is there a right treatment for a particular patient group? Comparison of ordinary treatment, light multidisciplinary treatment, and extensive multidisciplinary treatment for long-term sick-listed employees with musculoskeletal pain. Pain. 2002 Jan;95(1-2):49-63. doi: 10.1016/s0304-3959(01)00374-8.'}]}, 'descriptionModule': {'briefSummary': 'Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.\n\nWe would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.', 'detailedDescription': 'Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.\n\nA Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.\n\nTherefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.\n\nEven though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.\n\n* mainly biological\n* both biological and psychological\n* both biological and social\n* both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unspecific low back pain\n* Level of low back pain must be at least equal to leg pain\n* Patients must have been sick listed during the past 12 months\n* Age \\> 17 years and \\< than 60\n\nExclusion Criteria:\n\n* Modic changes as seen on MRI\n* Direct or progressive paresis or Cauda equina syndrome\n* Known MB Bechterew or Sacroiliitis\n* Suspicion of other serious malignancy\n* Alcohol or medicine abuse\n* A screening result of more than 30 in the Beck Depression Inventory'}, 'identificationModule': {'nctId': 'NCT00459433', 'briefTitle': 'The Right Intervention for the Right Patient', 'organization': {'class': 'OTHER', 'fullName': 'The Back Research Center, Denmark'}, 'officialTitle': 'The Right Intervention for the Right Patient', 'orgStudyIdInfo': {'id': '258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'psychosocial intervention', 'interventionNames': ['Procedure: Biopsychosocial intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual care', 'interventionNames': ['Procedure: Biopsychosocial intervention']}], 'interventions': [{'name': 'Biopsychosocial intervention', 'type': 'PROCEDURE', 'description': 'Psychosocial versus usual care', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5750', 'city': 'Ringe', 'country': 'Denmark', 'facility': 'The Back Research Center', 'geoPoint': {'lat': 55.23828, 'lon': 10.4786}}], 'overallOfficials': [{'name': 'Bendt Johansen, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated with University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Back Research Center, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Bendt Johansen, MHS', 'oldOrganization': 'The Back Research Center, Denmark'}}}}