Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05212194
Status:
UNKNOWN
Last Update Posted:
2022-02-10
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Post Dural Puncture Headache and Joint Laxity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post dural puncture headache (PDPH) severity', 'timeFrame': '24 hours after spinal anesthesia', 'description': 'The patients that occured PDPH will evaluate and classificate as mild,moderate and severe according to severity of PDPH by using Lybecker classification.'}, {'measure': 'joint laxity score', 'timeFrame': '24 hours after spinal anesthesia', 'description': 'The Beighton score is a simple system to quantify joint laxity and hypermobility. It uses a simple 9 point system, where the higher the score the higher the laxity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postdural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'Post-spinal headache is divided into 3 according to the severity scale. It is divided into 3 groups as mild, moderate and severe according to the presence of symptoms such as nausea, vomiting, and dizziness that prevent daily activity.\n\nIt has been reported that CSF leakage may be higher due to the weakness of the regional dural sac in primary connective tissue diseases with joint laxity and isolated joint hypermobility. Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.\n\nIn this study, it was aimed to investigate whether joint laxity contributes to the development of post-spinal headache by questioning the correlation between joint laxity examination score and postspinal headache in patients with post-spinal headache.', 'detailedDescription': 'Post dural puncture headache (PDPH), also known as post lumbar puncture (LP) headache, is a common complication of diagnostic LP. It also can occur following spinal anesthesia or, more commonly, inadvertent dural puncture during attempted epidural catheter placement. The headache is usually positional (worse when upright, better when lying flat) and is often accompanied by neck stiffness, photophobia, nausea, or subjective hearing symptoms.\n\nIn various studies, common patient risk factors for PDPH have included female gender, pregnancy, age 18 to 50 years compared with older or younger ages, and a prior history of headache\n\nAdditionally it has been thought that joint laxity contributes to the development of post dural puncture headache. However, no study has been found in the literature examining this relationship between them. In thıs study it was aimed to investigate the relationship between joint laxity and post dural puncture headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 age\n* the patients who develop PDPH\n\nExclusion Criteria:\n\n* \\<18 and \\>65 age\n* the patients refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT05212194', 'briefTitle': 'The Relationship Between Post Dural Puncture Headache and Joint Laxity', 'organization': {'class': 'OTHER', 'fullName': 'Adiyaman University Research Hospital'}, 'officialTitle': 'The Relationship Between Post Dural Puncture Headache and Joint Laxity', 'orgStudyIdInfo': {'id': '2021/10-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Post spinal puncture headache', 'description': 'the patients who developed post spinal puncture headache', 'interventionNames': ['Other: examination']}], 'interventions': [{'name': 'examination', 'type': 'OTHER', 'otherNames': ['joint laxity examination'], 'description': 'Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.', 'armGroupLabels': ['Post spinal puncture headache']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02200', 'city': 'Adıyaman', 'country': 'Turkey (Türkiye)', 'facility': 'Adıyaman Training and Research Hospital', 'geoPoint': {'lat': 37.76441, 'lon': 38.27629}}], 'centralContacts': [{'name': 'Nezir Yılmaz, Dr', 'role': 'CONTACT', 'email': 'yilmaznezir@hotmail.com', 'phone': '+90 5068939496'}], 'overallOfficials': [{'name': 'Nezir yılmaz, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adiyaman Training and Research Hospital'}, {'name': 'Mustafa Çukurlu, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adiyaman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adiyaman University Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nezir Yılmaz', 'investigatorAffiliation': 'Adiyaman University Research Hospital'}}}}