Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-06 @ 5:17 AM
Study NCT ID:
NCT02892656
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2016-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population
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': 'ACTUAL', 'count': 152}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Self-efficacy questionnaire', 'timeFrame': '12 months', 'description': 'The PSEQ consists of 10 items, each item is scored on a seven-point Likert scale with responses ranging from 0 (not at all confident) to 6 (completely confident). A total score is calculated by summing the scores of the 10 items yielding a total sum score ranging from 0-60. Higher scores indicate a stronger self-efficacy belief'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '34062626', 'type': 'DERIVED', 'citation': 'Vejlgaard C, Maribo T, Riisgaard Laursen J, Schmidt AM. Reliability and smallest detectable change of the Danish version of the Pain Self-Efficacy Questionnaire in patients with chronic low back pain. Scand J Pain. 2021 Jun 2;21(4):809-813. doi: 10.1515/sjpain-2021-0014. Print 2021 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.', 'detailedDescription': 'Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.\n\nAn important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.\n\nThe measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.\n\nIt is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic low back pain (defined as pain lasting for more than 12 months) with or without sciatica and/or with or without generalized pain identified by ICD-10 codes.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• referred to The Danish Rheumatism Associations' rehabilitation centre Sano\n\nExclusion criteria:\n\n* a rated physical status of \\> 3 according to the American Society of Anesthesiologists Physical Status Classification System\n* axial spondyloarthritis\n* spinal fracture within the last 3 months\n* severe osteoporosis\n* active cancer\n* active psychiatric pathology assessed by general practitioner before referral\n* pregnancy\n* low Danish language skills\n* no e-mail address"}, 'identificationModule': {'nctId': 'NCT02892656', 'briefTitle': 'Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population', 'organization': {'class': 'OTHER', 'fullName': 'Sano'}, 'officialTitle': 'Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'Sano 2'}}, 'contactsLocationsModule': {'locations': [{'zip': '5500', 'city': 'Middelfart', 'country': 'Denmark', 'facility': 'Sano', 'geoPoint': {'lat': 55.50591, 'lon': 9.73054}}, {'zip': '4230', 'city': 'Skælskør', 'country': 'Denmark', 'facility': 'Sano', 'geoPoint': {'lat': 55.25058, 'lon': 11.29352}}], 'overallOfficials': [{'name': 'Anne Mette Schmidt, Msc. H.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}