Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-31 @ 1:19 PM
Study NCT ID:
NCT04931758
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2021-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain
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': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-11', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-test of French version of FreBAQ on 20 representative patients', 'timeFrame': 'Baseline', 'description': '9-item self-administered questionnaire newly translated into French using a standard translation-retro-translation system, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)'}], 'secondaryOutcomes': [{'measure': 'FreBAQ score', 'timeFrame': 'Day 0', 'description': 'a 9-item self-administered questionnaire, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)'}, {'measure': 'FreBAQ score in a subgroup of 50 subjects (35 patients and 15 controls)', 'timeFrame': 'Day 7', 'description': 'a 9-item self-administered questionnaire, each item measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)'}, {'measure': 'Evaluation of the internal consistency of the French version of the FreBAQ', 'timeFrame': 'Day 0', 'description': "Analyzed by calculating Cronbach's alpha."}, {'measure': 'Evaluation of the unidimensionality of the French version of the FreBAQ', 'timeFrame': 'Day 0', 'description': 'Analyzed using principal component analysis methods'}, {'measure': 'Assessment of the reliability (test-retest) of the questionnaire in French', 'timeFrame': 'Day 7', 'description': "Measurement of the reliability of the questionnaire in French between the initial test and a test at Day 7: calculation of Bland \\& Altman's limits of agreement,"}, {'measure': 'Assessment of the reproducibility (test-retest) of the questionnaire in French', 'timeFrame': 'Day 7', 'description': 'Measurement of the reproducibility of the questionnaire in French between the initial test and a test at Day 7: calculation of the intra-class correlation coefficient'}, {'measure': 'Assessment of the discriminant validity of the questionnaire in French', 'timeFrame': 'Day 0', 'description': 'Comparison of scores between control subjects and chronic low back pain patients by calculating the area under the ROC curve'}, {'measure': 'Assessment of the concurrent validity', 'timeFrame': 'Day 0', 'description': 'Correlation of the French questionnaire score with the duration of low back pain'}, {'measure': 'Correlation of the French questionnaire score with lumbar visual analog scale (VAS) at rest', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with VAS result'}, {'measure': 'Correlation of the French questionnaire score with lumbar VAS in movement', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with VAS result'}, {'measure': 'Correlation of the French questionnaire score with disability', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with Oswestry Disability Index - a 10-section questionnaire with a results calculated as a percentage'}, {'measure': 'Correlation of the French questionnaire score with false beliefs', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with back beliefs questionnaire - a 14-tem questionnaire on a 0-5 scale'}, {'measure': 'Correlation of the French questionnaire score with fear avoidance beliefs', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with Fear Avoidance Belief Questionnaire - 16-item questionnaire scored between 0-6. Scale 1 = beliefs about work with a score ranging from 0 -42; Scale 2 = beliefs about physical activity with a score ranging from 0-24'}, {'measure': 'Correlation of the French questionnaire score with kinesiophobia', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with Tampa scale of Kinesiophobia - total score 68, with a cut-off of 40 for significant kinesiophobia'}, {'measure': 'Correlation of the French questionnaire score with catastrophism', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with Pain Catastrophizing Scale - a 13-item questionnaire on a 0-4 Likert scale'}, {'measure': 'Correlation of the French questionnaire score with anxiety and depression', 'timeFrame': 'Day 0', 'description': 'FreBAQ score compared with Hospital Anxiety and Depression Scale - a 14-item questionnaire on a 0-9 Likert scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '40066561', 'type': 'RESULT', 'citation': 'Homs AF, Ragon A, Mura T, Terribile G, Alonso S, Dupeyron AF. Validation of the French version of the Fremantle Back Awareness Questionnaire in patients with chronic low back pain. Eur J Phys Rehabil Med. 2025 Apr;61(2):295-304. doi: 10.23736/S1973-9087.24.08412-0. Epub 2025 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'In patients with chronic low back pain, the Fremantle Back Awareness Questionnaire (FreBAQ) measures the duration and intensity of pain and functional limitations. The FreBAQ is a simple tool created to assess disturbances in the body representation of the back, and the only one existing in chronic low back pain. It is a 9-item self-questionnaire in which each item is measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)". It assesses neglect, perceived body image of the back, accuracy in proprioceptive perception of back movements.\n\nThe psychometric properties of the FreBAQ in English, Japanese, Dutch, Turkish and German are validated and acceptable; however, they have never been studied in French and no validated version of this questionnaire in French exists.\n\nThe study investigators hypothesize that the French version of the FreBAQ has good psychometric qualities, allowing it to be used in the French chronic low back pain population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic low back pain defined as pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months followed in the Physical Medicine and Rehabilitation Department of the CHU of Nîmes and persons recruited among the members of the service and their entourage, as well as all patients coming for consultation in the service with no history of chronic low back pain and lumbar VAS \\< 2 for more than 3 months.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with no history of chronic low back pain and with a lumbar VAS \\<2 for more than 3 months.\n* Patient with chronic low back pain: pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months.\n* Patient with a lumbar VAS \\> 2 for more than 3 months.\n* Patient whose low back pain is of common origin (no underlying organic etiology).\n* In case of lumbar-radicular pain, patient with a VAS (lumbar) \\> VAS (leg)\n* Patient who speaks and understands French\n* Patient with no history of arthrodesis or lumbar disc prosthesis\n* Subject affiliated or beneficiary of a health insurance plan.\n* The patient must have given their free and informed consent and signed the consent form\n\nExclusion Criteria:\n\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient pregnant, parturient or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04931758', 'acronym': 'FreBAQ', 'briefTitle': 'Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'NIMAO/2020-2/AH-1'}, 'secondaryIdInfos': [{'id': '2021-A00373-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with low back pain', 'interventionNames': ['Other: Pain Questionnaire']}, {'label': 'Controls', 'interventionNames': ['Other: Pain Questionnaire']}], 'interventions': [{'name': 'Pain Questionnaire', 'type': 'OTHER', 'description': 'Subjects will take the FreBAQ questionnaire at Day 0 and a subgroup of 35 controls and 15 patients will take the same questionnaire at Day 7', 'armGroupLabels': ['Controls', 'Patients with low back pain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Alexis Homs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}