Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 4:47 PM
Study NCT ID:
NCT06622356
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2024-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C073590', 'term': 'gadolinium ethoxybenzyl DTPA'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biological samples were not designed for this study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-09-28', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SAS（Pain rating scale）', 'timeFrame': '12-18 months after surgery', 'description': "The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar Degenerative disease', 'PLIF', 'Sarcopenia', 'Sagittal balance', 'Machine learning', 'SVM', 'Cross Validation'], 'conditions': ['Lumbar Disc Herniation', 'Lumbar Degenerative Disease', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS\\<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;\n2. lumbar spinal fusion surgical treatment with PLIF;\n3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 12-18 month postoperative follow-up;\n4. observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.\n\nExclusion Criteria:\n\n(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.'}, 'identificationModule': {'nctId': 'NCT06622356', 'briefTitle': 'Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Suzhou Medical College'}, 'officialTitle': 'Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up', 'orgStudyIdInfo': {'id': '(2024) Lun Yan Grant No. 517'}, 'secondaryIdInfos': [{'id': '(2024) Lun Yan Grant No. 517', 'type': 'OTHER', 'domain': 'Medical Ethics Committee of the First Affiliated Hospital of Soochow University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rehabilitation Group', 'description': 'Rehabilitation Group (n = 268): mild/non pain group with VAS\\<3 at 12-18 months after PLIF。The study was retrospective and did not design an intervention', 'interventionNames': ['Other: MRI with Eovist']}, {'label': 'Recurrent pain group', 'description': 'Recurrent pain group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF', 'interventionNames': ['Other: MRI with Eovist']}], 'interventions': [{'name': 'MRI with Eovist', 'type': 'OTHER', 'description': 'The study was retrospective and did not design an intervention', 'armGroupLabels': ['Recurrent pain group', 'Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Medical record system and imaging system of the First Affiliated Hospital of Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Before January 1,2025;in the form of paper.The original data of the trial will be uploaded to Genome Sequence Archive (GSA) (ngdc.cncb.ac.cn)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hao Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgeon, First Affiliated Hospital of Suzhou University, Jiangsu Province, China', 'investigatorFullName': 'Hao Liu', 'investigatorAffiliation': 'First Affiliated Hospital of Suzhou Medical College'}}}}