Modified Lumbar Puncture for Spinal Tap Headache
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Chronic headaches, Neurosurgical implants, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this study is to o determine whether the modified LP procedure reduces the incidence of PLPH to 5% or lower, to determine whether the modified LP procedure reduces the frequency of epidural blood patch (EBP) usage to 10% or lower of the PLPH population and to identify factors that may contribute to or reduce incidence of PLPH
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulant or antiplatelet therapy, you must stop these before the lumbar puncture as per standard care guidance.
What data supports the effectiveness of the treatment Modified Lumbar Puncture for reducing spinal tap headaches?
Research suggests that using smaller needles during a lumbar puncture can reduce the frequency of headaches afterward, which may support the effectiveness of modified lumbar puncture techniques in minimizing this common complication.
12345Is the modified lumbar puncture procedure safe for humans?
Lumbar punctures are generally safe, but they can cause headaches in about one-third of patients. Using special atraumatic needles can reduce the risk of these headaches.
15678How does the Modified Lumbar Puncture treatment differ from other treatments for spinal tap headache?
The Modified Lumbar Puncture treatment is unique because it involves a controlled approach to the lumbar puncture procedure, which may help reduce the risk of post-lumbar puncture headache, a common complication. This approach might include using smaller needles or specific techniques to minimize the headache risk, unlike standard lumbar punctures.
12459Eligibility Criteria
This trial is for individuals who need a lumbar puncture (LP) for diagnostic or therapeutic reasons, can consent to the study, will follow all procedures, and have a Karnofsky Performance Scale score of 60 or above. It excludes those on certain blood thinners unless stopped as per guidelines, with chronic or acute headaches, recent neurosurgical implants, multiple dural punctures in one LP session, coagulopathy issues, procedural complications requiring needle changes, suspected high brain pressure or severe spinal deformities.Inclusion Criteria
I am getting a lumbar puncture as part of my standard care.
Participants who can sign informed consent
I am willing and able to follow all study procedures for its duration.
+1 more
Exclusion Criteria
I am not currently on blood thinners, or I can stop them as advised by my doctor.
You recently had a surgical device implanted in your brain.
I have a history of chronic or frequent headaches.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo the modified lumbar puncture procedure
1 day
1 visit (in-person)
Follow-up
Participants are monitored for post-lumbar puncture headaches and other outcomes
5 days
1 visit (virtual or phone call)
Participant Groups
The study tests whether a modified LP procedure can lower the occurrence of post-lumbar puncture headaches to 5% or less and reduce the need for epidural blood patch treatments to below 10% among those affected. It also aims to identify factors influencing these headaches' incidence.
1Treatment groups
Experimental Treatment
Group I: Modified Lumbar PunctureExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
References
Risk factors for post lumbar puncture headache. [2015]Lumbar puncture (LP) is complicated by headache in about one-third of patients. The aim of the study was to evaluate potential risk factors for post-LP headache.
Headache after lumbar puncture: randomised crossover trial of 22-gauge versus 25-gauge needles. [2014]To compare the frequency of headache and the procedure time following lumbar puncture (LP) using a 25-gauge needle compared to a 22-gauge needle.
Epidemiology of lumbar punctures in hospitalized patients in the United States. [2022]Lumbar puncture (LP) is an important technique for assessing and treating neurological symptoms. The objective of this study was to describe the characteristics of diagnostic lumbar punctures performed on hospitalized patients in the United States.
[Postdural puncture headache: diagnosis, prevention and therapy]. [2006]Lumbar puncture (LP) is a routine technique performed for a variety of procedures, e.g. diagnosis, administration of drugs, myelography and spinal anaesthesia. Postdural puncture headache is a common complication (30-40% in diagnostic LP). Prevention can be accomplished by using small-gauge needles (
Post-lumbar puncture headache: an adverse effect in multiple sclerosis work-up. [2021]Lumbar puncture (LP) is a safe procedure commonly performed in the diagnostic work-up of multiple sclerosis (MS), and its main adverse event is post-LP headache (PLPH). Predictors for PLPH in MS are not established.
Postdural puncture headache: impact of needle type, a randomized trial. [2019]The most common adverse event after a lumbar puncture (LP) is a headache: In anaesthesiology, well studied is the protective effect of atraumatic spinal needles, and they are routinely used. However, this is less well known in diagnostic LP, and neurologists use atraumatic needles in less than 2% of times.
A protocol to reduce self-reported pain scores and adverse events following lumbar punctures in older adults. [2021]Lumbar punctures (LPs) are important for obtaining CSF in neurology studies but are associated with adverse events and feared by many patients. We determined adverse event rates and pain scores in patients prospectively enrolled in two cohort studies who underwent LPs using a standardized protocol and 25 g needle.
Change practice now! Using atraumatic needles to prevent post lumbar puncture headache. [2015]Lumbar puncture (LP) is a key diagnostic procedure in medicine. Post lumbar puncture headache (PLPHA) is a well recognized complication of LP. Evidence suggests that using atraumatic needles for diagnostic LP (ATNLP) reduces risk of PLPHA. However, clinicians in Europe and the USA routinely use traumatic needles for diagnostic LP (TNLP). The occurrence of PLPHA following ATNLP and TNLP was compared in a clinical setting. Further, a survey was performed exploring use of ATNLP amongst UK neurologists.
Evaluation of the effects of resting in appearance of post lumbar puncture headache. [2015]Lumbar puncture (LP) is a procedure for obtaining spinal fluid from spinal meningeal spaces this can be done as a diagnostic or therapeutic procedure which can result in to a typical positional headache named as post lumbar puncture headache .This can cause a lot of discomforts for patients and makes fear from the procedure. This study designed to evaluate the effect of resting position after LP on post lumbar puncture headache (PLPH). Patients who had a diagnostic lumbar puncture were divided randomly in two groups .Group A patients had one hour rest in the supine position while group B patients had one hour rest in the prone position. Both groups followed for appearance of symptoms of PLPH for 5 days. 119 patients completed the study, 57 (48%) male patients and 62 (52%) female .PLPH totally appeared in 38 (31.9%) patients .In the group A PLPH was present in 20 patients whereas in group B it was present in 18 patients. Statistical analysis showed no significant differences between two groups (P>0.07). Position of rest after LP has no significant effect on reducing post lumbar puncture headache and there is no need to emphasize on position of rest after LP.