Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT07256132
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Erector Spinae Plane Block for the Relief of Chronic Pain in Cases of Degenerative Disc Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': '8 weeks', 'description': 'otal scores range from 0 to 10 (based on a scale of 0 to 2 for five items), with a higher score indicating more severe pain.'}], 'secondaryOutcomes': [{'measure': 'Oswestry disability index', 'timeFrame': '8 weeks', 'description': 'a condition-specific functional measure used to assess the symptoms and severity of low back pain disablement and its impact on patient functional activities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain in Degenerative Disc Diseases']}, 'descriptionModule': {'briefSummary': 'Erector Spinae Plane Block is an effective pain therapy technique to relieve chronic low back pain in cases of degenerative disc disorders.', 'detailedDescription': 'This study will be conducted on 40 adult patients with degenerative disc disease (DDD) of the lumbar spine and admitted to the Neurosurgery Department at Alexandria Main University Hospital aged between 30 and 65 years old with Visual analog scale more than or equal to 4 not responding to conservative treatment, patients having grade 0, 1 or 2 lumbar disc degeneration without disc bulge or prolapse by X-ray and MRI with loss or decreased lumbar lordosis, patients with black disc and contained disc bulge on magnetic resonance imaging (MRI) and patients with grade I degenerative spondylolisthesis provided that the canal dimensions are normal or with mild stenosis. Patients with severe sciatic pain, patients with more than two levels of DDD of the lumbar region or with isthmic spondylolisthesis and high-grade instability, or patients with disc fragments encroaching upon the exit foramina and nerve root or with severe canal stenosis, also those with central obesity, recurrent disc prolapse or with previous abdominal surgery were excluded from the study. Steroid injection will avoided in patients with immunosuppression or uncontrolled diabetes.\n\nBoth a full history taking and a clinical examination will be completed. All patients underwent an MRI of the lumbar region for evaluation. Routine laboratory and other lab investigations will conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study was conducted on 40 adult patients with degenerative disc disease (DDD) of the lumbar spine and admitted to the Neurosurgery Department at Alexandria Main University Hospital aged between 30 and 65 years old with Visual analog scale more than or equal to 4 not responding to conservative treatment, patients having grade 0, 1 or 2 lumbar disc degeneration without disc bulge or prolapse by X-ray and MRI with loss or decreased lumbar lordosis, patients with black disc and contained disc bulge on magnetic resonance imaging (MRI) and patients with grade I degenerative spondylolisthesis provided that the canal dimensions are normal or with mild stenosis\n\nExclusion Criteria:\n\n* Patients with severe sciatic pain, patients with more than two levels of DDD of the lumbar region or with isthmic spondylolisthesis and high-grade instability, or patients with disc fragments encroaching upon the exit foramina and nerve root or with severe canal stenosis, also those with central obesity, recurrent disc prolapse or with previous abdominal surgery were excluded from the study. Steroid injection was avoided in patients with immunosuppression or uncontrolled diabetes.'}, 'identificationModule': {'nctId': 'NCT07256132', 'briefTitle': 'The Efficacy of Erector Spinae Plane Block for the Relief of Chronic Pain in Cases of Degenerative Disc Diseases.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Efficacy of Erector Spinae Plane Block for the Relief of Chronic Pain in Cases of Degenerative Disc Diseases.', 'orgStudyIdInfo': {'id': '0305626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'injected patients', 'interventionNames': ['Procedure: erector spinae plane block']}, {'type': 'NO_INTERVENTION', 'label': 'care provider'}], 'interventions': [{'name': 'erector spinae plane block', 'type': 'PROCEDURE', 'description': 'erector spinae plane block', 'armGroupLabels': ['injected patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}