The Relationship Between Post Dural Puncture Headache and Joint Laxity
1 other identifier
interventional
80
1 country
1
Brief Summary
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. It 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. In 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 10, 2022
January 1, 2022
2 months
January 14, 2022
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Post dural puncture headache (PDPH) severity
The patients that occured PDPH will evaluate and classificate as mild,moderate and severe according to severity of PDPH by using Lybecker classification.
24 hours after spinal anesthesia
joint laxity score
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.
24 hours after spinal anesthesia
Study Arms (1)
Post spinal puncture headache
OTHERthe patients who developed post spinal puncture headache
Interventions
Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.
Eligibility Criteria
You may qualify if:
- age
- the patients who develop PDPH
You may not qualify if:
- \<18 and \>65 age
- the patients refused to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adıyaman Training and Research Hospital
Adıyaman, 02200, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nezir yılmaz, Dr
Adiyaman Training and Research Hospital
- STUDY DIRECTOR
Mustafa Çukurlu, Dr
Adiyaman Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
February 15, 2022
Primary Completion
April 1, 2022
Study Completion
September 1, 2022
Last Updated
February 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share