Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT03245294
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Contributing to the Pressure Wave Form Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-13', 'studyFirstSubmitDate': '2017-08-03', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pattern of epidural pressure decrease', 'timeFrame': '1 second after the completion of entry from ligamentum flavum to epidural space', 'description': 'abrupt or gradual decrease of epidural pressure'}], 'secondaryOutcomes': [{'measure': 'factors contributing the epidural pressure pattern', 'timeFrame': '60 minutes after the completion of entry from ligamentum flavum to epidural space', 'description': 'factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical epidural space', 'abrupt pressure decrease'], 'conditions': ['Analysis, Event History']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.', 'detailedDescription': 'Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is felt through the sudden decrease of pressure and this pressure gradient is generated when the needle is within the passage of interspinous ligament, ligamentum flavum and epidural space. The presence of ligamentum flavum is crucial for the identification of epidural space by LOR. However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament can modify this passage and a false LOR is generated consequentially. The false positive rate of the lumbar and cervical area was reported to be 8.3\\~17% and 30\\~68%, respectively. If the false positive rate is high, repeated attempts of epidural steroid injection (ESI) are required, with additional discomfort or pain to the patient.\n\nThe high rate of false LOR has prompted the design of adjunctive modalities. Among these, epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile wave coinciding with arterial pulsations can be seen through the monitor.\n\nRecent study suggested that significant abrupt pressure decrease occurs when cervical epidural injection was done via paramedian approach rather than midline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lumbar herniated nucleus\n* lumbar spinal stenosis\n* internal disc disruption\n* NRS \\> 5\n* ODI \\> 20\n\nExclusion Criteria:\n\n* coagulopathy\n* allergy to contrast media\n* infection at needle insertion site\n* absence of lumbar MRI\n* Pregnancy\n* previous lumbar spine surgery\n* neurological symptoms requiring prompt reevalution'}, 'identificationModule': {'nctId': 'NCT03245294', 'briefTitle': 'Factors Contributing to the Pressure Wave Form Changes', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections', 'orgStudyIdInfo': {'id': '2017-05-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar ESI with paramedian approach', 'description': 'Lumbar ESI with paramedian approach', 'interventionNames': ['Procedure: lumbar epidural injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbar ESI with midline approach', 'description': 'Lumbar ESI with midline approach', 'interventionNames': ['Procedure: lumbar epidural injection']}], 'interventions': [{'name': 'lumbar epidural injection', 'type': 'PROCEDURE', 'description': 'the pattern of pressure decrease from ligamentum flavum to epidural space', 'armGroupLabels': ['Lumbar ESI with midline approach', 'Lumbar ESI with paramedian approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Ji Hee Hong', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Ji Hee Hong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Hee Hong', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}