Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT04691193
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2020-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of STarT Back Screening Tool
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'STart Back screening Tool', 'timeFrame': 'within 6 month', 'description': 'to measure baseline risk of possible future poor outcome.'}, {'measure': 'Roland Morris Questionnaire', 'timeFrame': 'within 6 month', 'description': 'to determine function'}], 'secondaryOutcomes': [{'measure': 'Tampa Scale for Kinesiophobia', 'timeFrame': 'at the beginning', 'description': 'to determine kinesiophobia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sTart back secreening tool', 'low back pain'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '30580256', 'type': 'BACKGROUND', 'citation': 'Forsbrand MH, Grahn B, Hill JC, Petersson IF, Post Sennehed C, Stigmar K. Can the STarT Back Tool predict health-related quality of life and work ability after an acute/subacute episode with back or neck pain? A psychometric validation study in primary care. BMJ Open. 2018 Dec 22;8(12):e021748. doi: 10.1136/bmjopen-2018-021748.'}, {'pmid': '29625095', 'type': 'BACKGROUND', 'citation': 'Suri P, Delaney K, Rundell SD, Cherkin DC. Predictive Validity of the STarT Back Tool for Risk of Persistent Disabling Back Pain in a U.S. Primary Care Setting. Arch Phys Med Rehabil. 2018 Aug;99(8):1533-1539.e2. doi: 10.1016/j.apmr.2018.02.016. Epub 2018 Apr 3.'}, {'pmid': '18438893', 'type': 'RESULT', 'citation': 'Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008 May 15;59(5):632-41. doi: 10.1002/art.23563.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.', 'detailedDescription': 'Low back pain (LBP) is a common disorder that affects about 80% of adults at least once in a period of their life. 10% of low back pain becomes chronic and can affect the quality of life negatively and lead to disability. The STarT-Back-Tool was developed to identify people with poor prognosis, such as difficulty returning to work, loss of work force, disability. It has been reported that it would be beneficial to categorize patients according to their risk levels with this tool and plan treatment in primary care treatment centers. Being able to identify patients with a high probability of becoming chronic in the early period is very important to reduce or prevent disability that may occur. The aim of this study is to examine the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in patients presenting with low back pain complaints in the acute-subacute period and to examine the relationship between StArt Back Tool test and kinesophobia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years old\n* Low back pain for less than 3 months\n* Sign the written informed consent.\n* Being able to read and write\n\nExclusion Criteria:\n\n* Inflammatory rheumatologic disease\n* Having a history of lumbar surgery\n* Back pain for more than 3 months'}, 'identificationModule': {'nctId': 'NCT04691193', 'briefTitle': 'The Effect of STarT Back Screening Tool', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'The Effect of STarT Back Screening Tool in Determining Prognosis and Workforce Loss in Patients With Acute-Subacute Low Back Pain and Its Relationship With Kinesiophobia', 'orgStudyIdInfo': {'id': 'DiskapiYBERH2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study and control group', 'description': 'The study group included patients with low back pain for less than 3 months. The control group consists of healthy volunteers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'DiskapiYBERH', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Nihal Tezel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'nihal tezel', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}