Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT03994861
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2019-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dutch Version Fear-Avoidance Component Scale (FACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with musculoskeletal disorders are compared to matched healthy controls.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The fear-avoidance component scale (FACS)', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100'}, {'measure': 'The fear-avoidance component scale (FACS)', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating fear-avoidance related to pain (for all participants) 20 items range from 0-100'}, {'measure': 'Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale'}, {'measure': 'Disabilities of the arm, shoulder and hand questionnaire (DASH) for shoulder pain patients', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating disability (only used in patients with shoulder pain) 30 items Range total score 0-100 5 point-scale'}, {'measure': 'Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating disability (only used in patients with hip pain) Subscores per domain 40 items 5 point scale 5 domains: symptoms (5 items), pain (10 items), activities of daily living (17 items), sport and leisure time (4 items), quality of life (4 items)'}, {'measure': 'Hip disability and Osteoarthritis Outcome Score (HOOS) for hip pain patients', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating disability (only used in patients with hip pain) Subscores per domain 40 items 5 point scale 5 domains: symptoms (5 items), pain (10 items), activities of daily living (17 items), sport and leisure time (4 items), quality of life (4 items)'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating disability (only used in patients with knee pain) Subscores per domain 42 items 5 domains: pain (9 items), symptoms (7 items), activities of daily life (17 items), sports and leisure (5 items), quality of life (4 items) 5 point Likert scale'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score (KOOS) for knee pain patients', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating disability (only used in patients with knee pain) Subscores per domain 42 items 5 domains: pain (9 items), symptoms (7 items), activities of daily life (17 items), sports and leisure (5 items), quality of life (4 items) 5 point Likert scale'}, {'measure': 'Oswestry Disability Index for patients with low back pain', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100'}, {'measure': 'Oswestry Disability Index for patients with low back pain', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating disability (only used in patients with low back pain) 10 items Total score range from 0-100'}, {'measure': 'Neck Disability Index for neck pain patients', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100'}, {'measure': 'Neck Disability Index for neck pain patients', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating disability (only used in patients with neck pain) 10 items Total score range from 0-100'}, {'measure': 'Fear-avoidance beliefs questionnaire', 'timeFrame': 'day 0', 'description': '3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)'}, {'measure': 'Fear-avoidance beliefs questionnaire', 'timeFrame': 'day 7', 'description': '3 subscales: physical activity (4 items; 0-30), work (7 items; 0-66) and rest (5 items)'}, {'measure': 'Tampa scale for kinesiophobia', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68'}, {'measure': 'Tampa scale for kinesiophobia', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating kinesiophobia related to pain (for all participants) 17 items total score from 17-68'}, {'measure': 'Pain catastrophizing scale', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52'}, {'measure': 'Pain catastrophizing scale', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating catastrophizing (for all participants) 13 items 5 point Likert Scale Total score 0-52'}, {'measure': 'IEQ-Dutch scale for perceived injustice', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48'}, {'measure': 'IEQ-Dutch scale for perceived injustice', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating perceived injustice (for all participants) 12 items 5 point Likert-scale Total score range 0-48'}, {'measure': 'Hospital anxiety and depression scale', 'timeFrame': 'day 0', 'description': 'Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale'}, {'measure': 'Hospital anxiety and depression scale', 'timeFrame': 'day 7', 'description': 'Questionnaire evaluating anxiety and depression (for all participants) 2 subscales: anxiety (7 items) and depression (7 items) Total score 0-21 per subscale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain', 'Musculoskeletal Pain Disorder', 'Fear of Pain', 'Fear of Injury', 'Low Back Pain, Recurrent', 'Neck Pain', 'Shoulder Pain', 'Knee Pain Chronic', 'Hip Pain Chronic', 'PROMs']}, 'descriptionModule': {'briefSummary': "Chronic musculoskeletal disorders such as low back and neck pain are responsible for an enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from subacute to chronic low back pain. In patients with neck pain, those who were less fearful about harming their neck, had higher pain tolerance, which might have a positive impact on their level of disability. A new scale, the Fear-Avoidance Component Scale (FACS) was developed by Neblett, Mayer, Hartzell, Williams and Gatchel (2015) to assess FA. It consists of an all-encompassing set of constructs that more effectively deals with all critical issues of the FA concept than current scales do. Current scales have been criticized because of following findings: limited construct validity, little evidence on treatment responsiveness, a lack of evidence-based cut-off scores and items being too narrow or too general. The new scale comprehensively assesses all cognitive, emotional and behavioral components related to the updated version of the FA model by combining items of well-known scales in context of the FA model with items on one's perception of victimization and blame related to an injury. A Dutch version of the FACS is currently lacking. Subsequently, the aim of this study is to investigate different psychometric properties of the generated Dutch version in patients with musculoskeletal disorders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for all patients\n\n* between 18-80 years old\n* current pain complaint is not surgically treated\n* not being currently treated by a physiotherapist for pain complaint\n* Dutch language is mother tongue\n* At least 6 weeks of pain Exclusion criteria for all patients\n* Pain from a non-musculoskeletal origin (e.g., tumour)\n* neurological disease\n* impaired cognition Inclusion criteria for healthy controls\n* Not being disabled due to MSK pain based on cut-off per disability questionnaire\n* Between 18-80 years old\n* Dutch language is mother tongue'}, 'identificationModule': {'nctId': 'NCT03994861', 'briefTitle': 'Dutch Version Fear-Avoidance Component Scale (FACS)', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Validation and Reliability of the Dutch Version of the Fear-Avoidance Component Scale (FACS)', 'orgStudyIdInfo': {'id': '18.61/REVA18.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with musculoskeletal disorders', 'description': 'Patients with either shoulder pain, knee pain, hip pain, low back pain, pelvic pain or neck pain as their primary pain complaint, lasting for 6 weeks or longer', 'interventionNames': ['Diagnostic Test: Assessment of disability and behavior (by questionnaires)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy controls', 'description': 'Age- and gender-matched healthy controls (without musculoskeletal pain)', 'interventionNames': ['Diagnostic Test: Assessment of disability and behavior (by questionnaires)']}], 'interventions': [{'name': 'Assessment of disability and behavior (by questionnaires)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of disability and behavior (by questionnaires)', 'armGroupLabels': ['Healthy controls', 'Patients with musculoskeletal disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3590', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Lotte Janssens', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Annick Timmermans, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Lotte Janssens', 'investigatorAffiliation': 'Hasselt University'}}}}