What is this study trying to find out about post-lumbar puncture headaches?

This study is evaluating a modified lumbar puncture procedure to see if it can reduce the frequency of headaches that sometimes happen after the procedure. Researchers want to know if this new method lowers headache rates and reduces the need for additional treatments like epidural blood patches. The study is sponsored by The University of Texas Health Science Center, Houston.

Who may be eligible for this post-lumbar puncture headache clinical trial?

Adults aged 18 years or older who are scheduled to have a lumbar puncture for diagnostic or therapeutic reasons may be eligible. Participants must be able to provide informed consent and follow study procedures. People with chronic headaches or certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this post-lumbar puncture headache clinical trial?

Study-related care, including the lumbar puncture procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06062446

Study of a Modified Lumbar Puncture Procedure to Reduce Headaches After Lumbar Puncture in Adults

Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-13

100

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a modified lumbar puncture LP procedure designed to reduce the occurrence of post-lumbar puncture headaches PLPH in adult patients. This study aims to determine if this modified procedure can lower the incidence of PLPH to 5% or less, reduce the use of epidural blood patches EBP to 10% or less among those with PLPH, and identify factors influencing PLPH occurrence. The modified LP procedure involves using a 22 gauge Quincke spinal needle without reinserting the stylet after cerebrospinal fluid collection before removing the needle. Participants will undergo this modified procedure as part of their diagnostic or therapeutic care. The study is prospective and single-arm, focusing on adult patients receiving lumbar punctures according to standard medical care. Participants will be assessed for headaches at multiple time points 30 to 60 minutes, 1 day, 3 days, and 5 days after the procedure using questionnaires. Use of epidural blood patches will also be tracked at 1, 3, and 5 days post-LP. Participants must be able to consent and comply with study procedures, with their performance status considered. The total duration and follow-up details align with the scheduled assessments after the LP procedure.

CONDITIONS

Brief Title

A Prospective Study of a Modified Lumbar Puncture (LP) Procedure That Reduces Post-Lumbar Puncture Headaches (PLPH) in Patients

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants who can sign informed consent
Participants who have stated willingness to comply with all study procedures and availability for the duration of the study
Participants receiving a lumbar puncture per standard of care for diagnostic or therapeutic purposes
Participants with Karnofsky Performance Scale (KPS) of 60 or higher

You will not qualify if you...

Participants with a history of chronic headaches occurring 15 or more days per month or acute headaches
Participants with recent neurosurgical device implants such as ventriculoperitoneal shunt
Participants with more than one dural puncture during the same lumbar puncture procedure
Participants with chronic coagulopathy with elevated PT, PTT, or INR
Participants on active anticoagulant or antiplatelet therapy unless stopped prior to lumbar puncture per standard care
Participants suspected of raised intracranial pressure by clinical or imaging assessment
Participants with severe spinal column deformities such as scoliosis (disc diseases are not exclusion criteria)
Participants with lumbar puncture procedural complications requiring needle type or size change

Research Team

Jay-Jiguang Zhu, MD,PhD

Austin Lu

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Study of a Modified Lumbar Puncture Procedure to Reduce Headaches After Lumbar Puncture in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria