Headache After Diagnostic Lumbar Puncture (HELPUmeå)

Jonatan Salzer

Status: Completed

Conditions: Post-Lumbar Puncture Headache

Treatments: Device: Sprotte 22G needle, stylet not reinserted; Device: Sprotte 22G needle, stylet reinserted; Device: Sprotte 25G needle, stylet not reinserted; Device: Spinocan 25G needle, stylet reinserted; Device: Sprotte 25G needle, stylet reinserted; Device: Spinocan 25G needle, stylet not reinserted

Study type: Interventional

Funder types: Other

Identifiers

NCT03960749

HELP Umeå

Details and patient eligibility

About

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

Enrollment: 1,000 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 6 patient groups

Sprotte 25G needle, stylet reinserted

Experimental group

Treatment:

Device: Sprotte 25G needle, stylet reinserted

Sprotte 25G needle, stylet not reinserted

Experimental group

Treatment:

Device: Sprotte 25G needle, stylet not reinserted

Sprotte 22G needle, stylet reinserted

Experimental group

Treatment:

Device: Sprotte 22G needle, stylet reinserted

Sprotte 22G needle, stylet not reinserted

Experimental group

Treatment:

Device: Sprotte 22G needle, stylet not reinserted

Spinocan 25G needle, stylet reinserted

Experimental group

Treatment:

Device: Spinocan 25G needle, stylet reinserted

Spinocan 25G needle, stylet not reinserted

Experimental group

Treatment:

Device: Spinocan 25G needle, stylet not reinserted