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Headache After Diagnostic Lumbar Puncture

NCT ID: NCT03960749

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-28

Study Completion Date

2018-10-11

Brief Summary

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The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study:

1. Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
2. Sprotte 22 G (0.7 mm) atraumatic needle with introducer
3. Spinocan 25 G (0.5 mm) cutting needle

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Detailed Description

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Conditions

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Post-Lumbar Puncture Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.

Study Groups

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Sprotte 25G needle, stylet reinserted

Group Type EXPERIMENTAL

Sprotte 25G needle, stylet reinserted

Intervention Type DEVICE

Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 25G needle, stylet not reinserted

Group Type EXPERIMENTAL

Sprotte 25G needle, stylet not reinserted

Intervention Type DEVICE

Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal

Sprotte 22G needle, stylet reinserted

Group Type EXPERIMENTAL

Sprotte 22G needle, stylet reinserted

Intervention Type DEVICE

Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal

Sprotte 22G needle, stylet not reinserted

Group Type EXPERIMENTAL

Sprotte 22G needle, stylet not reinserted

Intervention Type DEVICE

Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal

Spinocan 25G needle, stylet reinserted

Group Type EXPERIMENTAL

Spinocan 25G needle, stylet reinserted

Intervention Type DEVICE

Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal

Spinocan 25G needle, stylet not reinserted

Group Type EXPERIMENTAL

Spinocan 25G needle, stylet not reinserted

Intervention Type DEVICE

Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Interventions

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Sprotte 25G needle, stylet reinserted

Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal

Intervention Type DEVICE

Sprotte 25G needle, stylet not reinserted

Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal

Intervention Type DEVICE

Sprotte 22G needle, stylet reinserted

Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal

Intervention Type DEVICE

Sprotte 22G needle, stylet not reinserted

Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal

Intervention Type DEVICE

Spinocan 25G needle, stylet reinserted

Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal

Intervention Type DEVICE

Spinocan 25G needle, stylet not reinserted

Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
* Willing to participate and
* Providing informed consent

Exclusion Criteria

-Subjects unable to participate in the study follow-up
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

Jonatan Salzer

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jonatan Salzer

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

References

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Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available.

Reference Type BACKGROUND
PMID: 11061243 (View on PubMed)

Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.

Reference Type BACKGROUND
PMID: 19009898 (View on PubMed)

Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.

Reference Type BACKGROUND
PMID: 16116106 (View on PubMed)

Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available.

Reference Type BACKGROUND
PMID: 9102578 (View on PubMed)

Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5.

Reference Type BACKGROUND
PMID: 21549395 (View on PubMed)

Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310.

Reference Type BACKGROUND
PMID: 11756618 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HELP Umeå

Identifier Type: -

Identifier Source: org_study_id

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