Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 6:37 PM
Study NCT ID:
NCT07061067
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability assessment', 'timeFrame': '6 months postoperatively', 'description': 'Disability assessment will be done by the Oswestry Disability Index (ODI). ODI is a pain-related disability score ranging from 0 (no impairment) to 100 (bedbound).'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '6 months postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").'}, {'measure': 'Musculoskeletal conditions', 'timeFrame': '6 months postoperatively', 'description': 'Global Perceived Effect (GPE) will be used to assess musculoskeletal conditions like neck pain. The GPE scale has seven steps (1=completely recovered, 2=much improved, 3=somewhat improved, 4=unchanged, 5=somewhat worse, 6=much worse, 7=worse than ever)'}, {'measure': 'Degree of patient satisfaction', 'timeFrame': '6 months postoperatively', 'description': 'Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Symptom Duration', 'Outcomes', 'Lumbar Spine Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery.', 'detailedDescription': 'Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation.\n\nThe first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective study will be carried out on 60 patients undergoing lumbar spine surgery admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old.\n* Both sexes.\n* Patients undergoing lumbar spine surgery\n* Presenting symptoms include lumbar back pain, lumbar radiculopathy, neurogenic claudication, lower-extremity weakness, bowel or bladder symptoms, and duration of symptoms.\n\nExclusion Criteria:\n\n* Previous spinal surgery.\n* Vascular claudication.\n* Comorbid pathology affecting walking ability.\n* Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).\n* Bony metastases.\n* Unfit for general anaesthesia.'}, 'identificationModule': {'nctId': 'NCT07061067', 'briefTitle': 'Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery', 'orgStudyIdInfo': {'id': 'KFSIRB200-644'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients undergoing lumbar spine surgery', 'interventionNames': ['Procedure: Lumbar Spine Surgery']}], 'interventions': [{'name': 'Lumbar Spine Surgery', 'type': 'PROCEDURE', 'description': 'Patients undergoing lumbar spine surgery Presenting symptoms include lumbar back pain, lumbar radiculopathy, neurogenic claudication, lower-extremity weakness, bowel or bladder symptoms, and duration of symptoms.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman M Basha, MD', 'role': 'CONTACT', 'email': 'aymanbasha424@gmail.com', 'phone': '00201063037278'}, {'name': 'Ahmed A Zahra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Ayman M Basha, MD', 'role': 'CONTACT', 'email': 'aymanbasha424@gmail.com', 'phone': '00201063037278'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt', 'investigatorFullName': 'Ayman Mohamed Basha', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}