Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT07193758
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-02
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Return to Work After Lumbar Surgery: a Nationwide Survey of Spinal Surgeons' Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reported practices regarding return to work advice and sick leave following lumbar surgery', 'timeFrame': 'Through study completion, an average of 3 months (anticipated January 2026)', 'description': 'Measured using a custom-designed online questionnaire. Topics include timing of advice, recommended duration of sick leave, and content of return-to-work guidance. Results reported as frequencies and percentages.'}], 'secondaryOutcomes': [{'measure': 'Reported barriers and facilitators to providing return to work guidance', 'timeFrame': 'Through study completion, an average of 3 months (anticipated January 2026)', 'description': 'Measured using multiple-choice and Likert-scale questions. Topics include professional-level barriers and facilitators. Results reported as frequencies, percentages, and mean Likert scores (1-5; higher = greater agreement).'}, {'measure': 'Surgeon demographics and practice characteristics', 'timeFrame': 'Through study completion, an average of 3 months (anticipated January 2026)', 'description': 'Demographic and professional background questions including age, sex, specialty, years in practice, hospital setting, and surgical case load. Results summarized as frequencies and percentages.'}, {'measure': 'Reported confidence and perceived responsibility in discussing return to work', 'timeFrame': 'Through study completion, an average of 3 months (anticipated January 2026)', 'description': 'Measured using 5-point Likert scale questions. Topics include self-reported confidence in discussing return-to-work and perceived responsibility among surgeons. Results reported as mean scores (1 = strongly disagree, 5 = strongly agree; higher scores = greater confidence/responsibility).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radicular pain', 'Lumbar surgery', 'Lumbar decompression', 'Lumbar discectomy', 'Lumbar fusion', 'Survey', 'Spinal surgeons', 'Return to work', 'Sick leave advice'], 'conditions': ['Radicular Pain', 'Lumbar Surgery', 'Radicular Pain Related to Lumbosacral Disc Disease', 'Fusion of Spine, Lumbar Region', 'Disc Herniation With Radiculopathy', 'Lumbar Decompression']}, 'descriptionModule': {'briefSummary': "This national cross-sectional survey investigates the current practices and perceptions of Belgian spinal surgeons regarding return to work (RTW) after lumbar surgery for radicular pain. The study aims to (1) assess surgeons' advice on RTW and sick leave, (2) identify barriers and facilitators encountered when providing RTW guidance, and (3) explore how these factors relate to surgeon characteristics such as demographics, hospital setting, and professional experience. The results will inform clinical practice recommendations and support the development of targeted interventions to improve RTW guidance.", 'detailedDescription': "Return to work (RTW) after lumbar surgery is shaped by a combination of medical, psychosocial, and system-level factors. Although clinical guidelines increasingly recognize RTW as an essential outcome, limited evidence exists on how surgeons address this issue in everyday practice and what challenges they encounter.\n\nThis national cross-sectional survey will be distributed to members of the Spine Society of Belgium (SSBe). It explores surgeons' demographics, current clinical practices regarding RTW advice and sick leave, communication strategies with patients, perceived professional roles and responsibilities, and barriers and facilitators in providing RTW guidance.\n\nThe findings will provide insights into current practices, highlight modifiable barriers, and support the development of evidence-based clinical recommendations and targeted interventions to optimize RTW guidance after lumbar surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Belgian spinal surgeons (orthopaedic surgeons and neurosurgeons) who perform lumbar surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orthopaedic surgeons or neurosurgeons who perform lumbar surgery in Belgium.\n* Members or affiliates of the Spine Society of Belgium (SSBe), as survey distribution will occur through the SSBe member list.\n* Willing to participate in the survey, as evidenced by voluntary completion of the online questionnaire. Informed consent is implied after reading the participant information sheet.\n\nExclusion Criteria:\n\n* Surgeons not performing lumbar surgery.\n* Surgeons not affiliated with SSBe.'}, 'identificationModule': {'nctId': 'NCT07193758', 'briefTitle': "Return to Work After Lumbar Surgery: a Nationwide Survey of Spinal Surgeons' Practices", 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': "Return to Work After Lumbar Surgery for Radicular Pain: a Nationwide Survey of Spinal Surgeons' Practices and Perceptions", 'orgStudyIdInfo': {'id': 'S70903'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Belgian spinal surgeons', 'description': 'Belgian spinal surgeons who are members of the Spine Society of Belgium (SSBe). The survey will be distributed through the SSBe membership list.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Sofie Rummens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study involves a small professional population (Belgian spinal surgeons), where sharing individual-level responses could risk indirect identification despite anonymization. Only aggregated, group-level results will be reported.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}