The Relationship Between Post Dural Puncture Headache and Joint Laxity

Postdural Puncture Headache Clinical Trial

Official title:

The Relationship Between Post Dural Puncture Headache and Joint Laxity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05212194
• Other study ID #: 2021/10-25
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2022
• Source: Adiyaman University Research Hospital
• Contact: Nezir Yilmaz, Dr
• Phone: +90 5068939496
• Email: yilmaznezir[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 age

• the patients who develop PDPH

Exclusion Criteria:

• <18 and >65 age

• the patients refused to participate in the study

Related Conditions & MeSH terms

• Headache
• Joint Instability
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Other:
• examination
Joint laxity is scored according to the level of motion in 5 different joints and a maximum of 9 points is obtained.

Locations

Country	Name	City	State
Turkey	Adiyaman Training and Research Hospital	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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