Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT06407167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropathic Pain in Patients With Degenerative Lumbar Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Oswestry Disability Index (ODI)', 'timeFrame': '3 months postoperatively', 'description': 'To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Neuropathic Pain 4 Questions (DN4)', 'timeFrame': '2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively', 'description': 'To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in Numeric Pain Rating Scale (NPRS)', 'timeFrame': '2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively', 'description': 'To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in Oswestry Disability Index (ODI)', 'timeFrame': '12 months postoperatively', 'description': 'To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in The Health Transition Item from SF-36 (HTI Item)', 'timeFrame': '2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively', 'description': 'To observe the change of The Health Transition Item as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in sagittal balance parameters', 'timeFrame': '3 months, 12 months postoperatively', 'description': 'To observe the change of sagittal balance parameters (index Barrey) as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in regional balance parameters', 'timeFrame': '3 months, 12 months postoperatively', 'description': 'To observe the change of regional balance parameters (Segmental Lordosis) as compared to baseline through follow-up terms'}, {'measure': 'Change from baseline in frontal balance parameters', 'timeFrame': '3 months, 12 months postoperatively', 'description': "To observe the change of frontal balance parameters (Cobb's angle) as compared to baseline through follow-up terms"}, {'measure': 'the safety parameters', 'timeFrame': 'during study, an average of 1 year', 'description': 'To observe and document the safety parameters (Adverse events)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis', 'Neuropathic Pain', 'Spinal Disease']}, 'descriptionModule': {'briefSummary': "Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure.\n\nThus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.", 'detailedDescription': 'The current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis.\n\nThis study will be conducted at Priorov Central Institute for Trauma and Orthopedics, Moscow, Russia.\n\nThe study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. The neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion.\n\nThe neuropathic pain will be evaluated according to DN4 preoperatively, each patient will be assigned to one of two groups depending on the total value of DN4 - with the presence of neuropathy (DN4\\>= 4) and without neuropathy (DN4 \\<4).\n\nPostoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'One study center in Russia will include adult patients with radicular leg pain with/without neurogenic claudication with/without back pain caused by degenerative spinal stenosis with MRI-confirmed nerve compression; with symptoms persisting for more than 3 months before surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-85 years;\n2. Radicular leg pain with or without neurogenic claudication with or without back pain;\n3. Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;\n4. Symptoms persisting for at least 3 months prior to surgery;\n5. Given written Informed Consent;\n6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements\n\nExclusion Criteria:\n\n1. Prior lumbar fusion at any level;\n2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;\n3. Back or non-radicular pain of unknown etiology;\n4. History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);\n5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;\n6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).'}, 'identificationModule': {'nctId': 'NCT06407167', 'briefTitle': 'Neuropathic Pain in Patients With Degenerative Lumbar Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'N.N. Priorov National Medical Research Center of Traumatology and Orthopedics'}, 'officialTitle': 'Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis', 'orgStudyIdInfo': {'id': 'NS12-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuropathic Pain', 'description': 'All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group', 'interventionNames': ['Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire']}, {'label': 'No Neuropathic Pain', 'description': 'All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group', 'interventionNames': ['Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire']}], 'interventions': [{'name': 'DN4 (Douleur Neuropathique 4 Questions) questionnaire', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['neuropathic pain diagnostic questionnaire'], 'description': 'DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination', 'armGroupLabels': ['Neuropathic Pain', 'No Neuropathic Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '127299', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Priorov National Medical Research Center of Traumatology and Orthopedics', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'N.N. Priorov National Medical Research Center of Traumatology and Orthopedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neurosurgery Department', 'investigatorFullName': 'Aleksandr Krutko', 'investigatorAffiliation': 'N.N. Priorov National Medical Research Center of Traumatology and Orthopedics'}}}}