The Relationship Between Post Dural Puncture Headache and Joint Laxity
Primary Purpose
Postdural Puncture Headache
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Postdural Puncture Headache
Eligibility Criteria
Inclusion Criteria:
- 18-65 age
- the patients who develop PDPH
Exclusion Criteria:
- <18 and >65 age
- the patients refused to participate in the study
Sites / Locations
- Adıyaman Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Post spinal puncture headache
Arm Description
the patients who developed post spinal puncture headache
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05212194
First Posted
January 14, 2022
Last Updated
January 27, 2022
Sponsor
Adiyaman University Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05212194
Brief Title
The Relationship Between Post Dural Puncture Headache and Joint Laxity
Official Title
The Relationship Between Post Dural Puncture Headache and Joint Laxity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2022 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
In 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
Additionally 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post spinal puncture headache
Arm Type
Other
Arm Description
the patients who developed post spinal puncture headache
Intervention Type
Other
Intervention Name(s)
examination
Other Intervention Name(s)
joint laxity examination
Intervention Description
Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.
Primary Outcome Measure Information:
Title
Post dural puncture headache (PDPH) severity
Description
The patients that occured PDPH will evaluate and classificate as mild,moderate and severe according to severity of PDPH by using Lybecker classification.
Time Frame
24 hours after spinal anesthesia
Title
joint laxity score
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.
Time Frame
24 hours after spinal anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 age
the patients who develop PDPH
Exclusion Criteria:
<18 and >65 age
the patients refused to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nezir Yılmaz, Dr
Phone
+90 5068939496
Email
yilmaznezir@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nezir yılmaz, Dr
Organizational Affiliation
Adiyaman Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustafa Çukurlu, Dr
Organizational Affiliation
Adiyaman Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Adıyaman Training and Research Hospital
City
Adıyaman
ZIP/Postal Code
02200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Relationship Between Post Dural Puncture Headache and Joint Laxity
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