Modified Lumbar Puncture for Spinal Tap Headache

Overseen By Austin Lu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Chronic headaches, Neurosurgical implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new lumbar puncture (spinal tap) technique can reduce the likelihood of post-procedure headaches. Researchers hope this method will also decrease the need for an epidural blood patch, a treatment used if headaches occur. Individuals requiring a lumbar puncture for medical reasons and without a history of frequent headaches (more than 15 days a month) might be suitable candidates for this study.

As an unphased study, this trial provides patients the opportunity to contribute to innovative research that could enhance lumbar puncture procedures.

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 prior data suggests that the modified lumbar puncture is safe?

In a previous study, about one-third of patients experienced headaches after a lumbar puncture. However, special needles designed to cause less damage can reduce this risk. Another study found that a carefully controlled lumbar puncture procedure improved headache symptoms both before and after the procedure. This suggests that the modified lumbar puncture might be safer and more comfortable for patients. Overall, these findings indicate that the modified lumbar puncture is well-tolerated, with fewer headaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the modified lumbar puncture because it could offer a new way to reduce spinal tap headaches. Unlike the traditional lumbar puncture, which can sometimes lead to headaches due to cerebrospinal fluid leakage, this modified approach might minimize that risk. By potentially altering the technique or tools used, this method aims to maintain the necessary diagnostic procedure while improving patient comfort and outcomes.

What evidence suggests that the Modified Lumbar Puncture is effective for reducing spinal tap headaches?

Research has shown that many people experience headaches after a lumbar puncture, especially with larger needles, with up to 70% encountering this side effect. However, smaller needles can reduce this rate to about 12%. In this trial, the Modified Lumbar Puncture, the experimental treatment under study, aims to lower the chance of headaches by altering the procedure. Experts agree that these new techniques show promise in reducing headaches. While more research is needed, using smaller needles and modifying the procedure may help minimize this common side effect. ^{1 2 3 4 6}

Who Is on the Research Team?

Jay-Jiguang Zhu, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Modified Lumbar Puncture

Trial Overview 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.

How Is the Trial Designed?

Group I: Modified Lumbar Puncture Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Postdural puncture headache occurs in 30-40% of patients after lumbar puncture, but can be effectively prevented by using smaller gauge or pencil-point needles.

The epidural blood patch is one of the most effective treatments for postdural puncture headache, with a success rate of 80-97%, while other treatments like theophylline and caffeine show promise but have variable efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postdural puncture headache: diagnosis, prevention and therapy]. Schwarz, U., Schwan, C., Strumpf, M., et al.[2006]

In a study of 809 lumbar punctures performed on 262 patients aged 60 and older, the overall adverse event rate was low at 2.72%, indicating that the procedure is relatively safe when following a standardized protocol.

The median pain score reported by patients was only 1 out of 10, suggesting that the procedure can be performed with minimal discomfort, and only 0.49% of patients experienced a post-lumbar puncture headache.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol to reduce self-reported pain scores and adverse events following lumbar punctures in older adults. Nobuhara, CK., Bullock, WM., Bunning, T., et al.[2021]

In a study involving patients over 14 years old undergoing lumbar punctures, the use of atraumatic (Sprotte) needles significantly reduced the incidence of postdural puncture headache (PDPH) to 8.51%, compared to 22.43% with traumatic (Quincke) needles.

Patients using atraumatic needles also experienced shorter durations of PDPH, with most lasting 1 day or less, while those with traumatic needles had a median duration of 4.14 days, highlighting the effectiveness of atraumatic needles in preventing and minimizing headache symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postdural puncture headache: impact of needle type, a randomized trial. Castrillo, A., Tabernero, C., García-Olmos, LM., et al.[2019]

In a study involving 93 children undergoing lumbar punctures, there was no significant difference in the occurrence of post-lumbar puncture headaches between the 22-gauge and 25-gauge needles, with rates of 7.2% and 4.6% respectively.

The use of the 25-gauge needle resulted in longer procedure times, but both needle sizes can be considered appropriate for lumbar punctures in children, depending on the specific circumstances and the operator's experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Headache after lumbar puncture: randomised crossover trial of 22-gauge versus 25-gauge needles. Crock, C., Orsini, F., Lee, KJ., et al.[2014]

In the United States, there were approximately 362,718 lumbar punctures performed in hospitals, highlighting its significance in diagnosing and treating neurological conditions.

The most common reasons for performing lumbar punctures were headaches and meningitis in adults, while in children, they were fever of unknown origin, meningitis, and seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology of lumbar punctures in hospitalized patients in the United States. Vickers, A., Donnelly, JP., Moore, JX., et al.[2022]

In a study of 144 patients undergoing lumbar puncture, 27.6% experienced post-LP headaches, with a higher incidence in younger patients and women, indicating demographic factors may influence headache risk.

A significant correlation was found between a history of headaches and post-LP headaches, as well as elevated opening pressure, suggesting these factors may contribute to the development of headaches after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for post lumbar puncture headache. Khlebtovsky, A., Weitzen, S., Steiner, I., et al.[2015]

In a study of 100 patients undergoing lumbar puncture for suspected multiple sclerosis, 57% experienced post-LP headache (PLPH) within 48 hours, highlighting this as a common complication of the procedure.

Age was identified as a predictor for PLPH at day 2, while both the onset of headache within 48 hours and female gender were predictors for PLPH persistence at day 7, suggesting that these factors may help identify patients at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-lumbar puncture headache: an adverse effect in multiple sclerosis work-up. Vecchio, D., Naldi, P., Ferro, V., et al.[2021]

Using atraumatic needles for lumbar punctures significantly reduces the occurrence of post lumbar puncture headache (PLPHA) compared to traumatic needles, with rates of 27.1% versus 60.4%, respectively.

Patients who experienced PLPHA after using atraumatic needles reported shorter and less severe symptoms, averaging 50 hours compared to 94 hours with traumatic needles, highlighting the efficacy of atraumatic needles in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change practice now! Using atraumatic needles to prevent post lumbar puncture headache. Davis, A., Dobson, R., Kaninia, S., et al.[2015]

In a study of 119 patients undergoing lumbar puncture, resting position (supine vs. prone) after the procedure did not significantly affect the occurrence of post lumbar puncture headache (PLPH), with 31.9% of patients experiencing PLPH overall.

Both resting positions resulted in similar rates of PLPH, indicating that there is no need to emphasize a specific resting position after lumbar puncture to prevent headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the effects of resting in appearance of post lumbar puncture headache. Afshinmajd, S., Davati, A., Ahmadvand, A., et al.[2015]

Citations

1. withpower.com withpower.com/trial/phase-post-dural-puncture-headache-9-2023-a41f9

Modified Lumbar Puncture for Spinal Tap Headache In a study of 144 patients undergoing lumbar puncture, 27.6% experienced post-LP headaches, with a higher incidence in younger patients and women, indicating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6376596/

Therapeutic lumbar puncture for headache in idiopathic ... Therapeutic lumbar punctures may be considered to manage headache. This study evaluated the acute effect of lumbar punctures on headache severity.

3. neurology.org neurology.org/doi/10.1212/WNL.55.7.909

Assessment: Prevention of post–lumbar puncture headaches The data are conflicting in the diagnostic LP literature, but the studies have, in general, been inadequate to assess the question. Open in Viewer Figure ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808365

Consensus Practice Guidelines on Postdural Puncture ... This consensus statement describes the process of creating evidence-based guidelines for postdural puncture headache that considered risk ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2660496/

Post lumbar puncture headache: diagnosis and management The incidence of headache is 70% if the needle size is between 16 and 19G, 40% if the needle size is between 20 and 22G and 12% if the needle size is between 24 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728282/

A controlled lumbar puncture procedure improves the safety of ... An integrated and controlled LP needle (n = 35) significantly improved patients' headache symptoms before and after puncture. In addition, a ...