Post-Lumbar Puncture HeadacheHELPUmeåNCT03960749
Headache After Diagnostic Lumbar Puncture
A study testing Sprotte 25G needle, stylet reinserted, Sprotte 25G needle, stylet not reinserted and Sprotte 22G needle, stylet reinserted in people with Post-Lumbar Puncture Headache, run by Jonatan Salzer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post-Lumbar Puncture Headache
- What is being tested?
- Sprotte 25G needle, stylet reinserted, Sprotte 25G needle, stylet not reinserted and Sprotte 22G needle, stylet reinserted
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2013to 11 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Subjects unable to participate in the study follow-up
About this study
Official title: The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
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:
- Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
- Sprotte 22 G (0.7 mm) atraumatic needle with introducer
- Spinocan 25 G (0.5 mm) cutting needle
- Conditions
- Post-Lumbar Puncture Headache
- Being tested
- Sprotte 25G needle, stylet reinserted, Sprotte 25G needle, stylet not reinserted, Sprotte 22G needle, stylet reinserted, Sprotte 22G needle, stylet not reinserted, Spinocan 25G needle, stylet reinserted
- Keywords
- Lumbar puncture, Headache
- Medical subject headings
- Post-Dural Puncture Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprotte 25G needle, stylet reinsertedDevice
Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
Sprotte 25G needle, stylet not reinsertedDevice
Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
Sprotte 22G needle, stylet reinsertedDevice
Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
Sprotte 22G needle, stylet not reinsertedDevice
Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
Spinocan 25G needle, stylet reinsertedDevice
Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
Spinocan 25G needle, stylet not reinsertedDevice
Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Sprotte 25G needle, stylet reinserted | Experimental | Not described Receives: Device: Sprotte 25G needle, stylet reinserted |
| Sprotte 25G needle, stylet not reinserted | Experimental | Not described Receives: Device: Sprotte 25G needle, stylet not reinserted |
| Sprotte 22G needle, stylet reinserted | Experimental | Not described Receives: Device: Sprotte 22G needle, stylet reinserted |
| Sprotte 22G needle, stylet not reinserted | Experimental | Not described Receives: Device: Sprotte 22G needle, stylet not reinserted |
| Spinocan 25G needle, stylet reinserted | Experimental | Not described Receives: Device: Spinocan 25G needle, stylet reinserted |
| Spinocan 25G needle, stylet not reinserted | Experimental | Not described Receives: Device: Spinocan 25G needle, stylet not reinserted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio for post-lumbar puncture headache (any)
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Measured: Up to 14 days after LP
Secondary outcomes (7)
Odds ratio for post-lumbar puncture headache (severe)
Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
Measured: Up to 14 days after LP
Headache duration (days)
Measured: Until cessation, up to 14 days after LP
Proportion using analgesia
Measured: During post-lumbar puncture headache, up to 14 days after LP
Proportion on sick leave
Measured: During post-lumbar puncture headache, up to 14 days after LP
Proportion with back pain
Measured: Up to 14 days after LP
Proportion with radiating leg pain
Measured: Up to 14 days after LP
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
Measured: Up to 14 days after LP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start28 May 2013
- Primary completion24 Jun 2018
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Lumbar Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonatan Salzer
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Sponsor-investigator, Jonatan Salzer, Region Västerbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960749
- Sponsor's protocol ID
- HELP Umeå
- Acronym
- HELPUmeå
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11061243Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
PubMed 19009898Armon 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.
PubMed 16116106Strupp 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.
PubMed 9102578Hammond 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.
PubMed 21549395Strupp 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.
PubMed 11756618
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03960749
- Acronym / sponsor ID
- HELPUmeå / HELP Umeå
- Conditions
- Post-Lumbar Puncture Headache
- Keywords
- Lumbar puncture, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jonatan SalzerOther government
- Collaborators
- Umeå University
- Study start
- 28 May 2013 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer
- Sprotte 22 G (0.7 mm) atraumatic needle with introducer
- Spinocan 25 G (0.5 mm) cutting needle
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
| Arm | Type | Receives |
|---|---|---|
| Sprotte 25G needle, stylet reinserted | Experimental | Device: Sprotte 25G needle, stylet reinserted |
| Sprotte 25G needle, stylet not reinserted | Experimental | Device: Sprotte 25G needle, stylet not reinserted |
| Sprotte 22G needle, stylet reinserted | Experimental | Device: Sprotte 22G needle, stylet reinserted |
| Sprotte 22G needle, stylet not reinserted | Experimental | Device: Sprotte 22G needle, stylet not reinserted |
| Spinocan 25G needle, stylet reinserted | Experimental | Device: Spinocan 25G needle, stylet reinserted |
| Spinocan 25G needle, stylet not reinserted | Experimental | Device: Spinocan 25G needle, stylet not reinserted |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Subjects unable to participate in the study follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprotte 25G needle, stylet reinsertedLumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal | Device | Sprotte 25G needle, stylet reinserted |
| Sprotte 25G needle, stylet not reinsertedLumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal | Device | Sprotte 25G needle, stylet not reinserted |
| Sprotte 22G needle, stylet reinsertedLumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal | Device | Sprotte 22G needle, stylet reinserted |
| Sprotte 22G needle, stylet not reinsertedLumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal | Device | Sprotte 22G needle, stylet not reinserted |
| Spinocan 25G needle, stylet reinsertedLumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal | Device | Spinocan 25G needle, stylet reinserted |
| Spinocan 25G needle, stylet not reinsertedLumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal | Device | Spinocan 25G needle, stylet not reinserted |
Primary outcome
Odds ratio for post-lumbar puncture headache (any)
Time frame: Up to 14 days after LP
Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
7 secondary outcomes
Odds ratio for post-lumbar puncture headache (severe)
Time frame: Up to 14 days after LP
Headache duration (days)
Time frame: Until cessation, up to 14 days after LP
Proportion using analgesia
Time frame: During post-lumbar puncture headache, up to 14 days after LP
Proportion on sick leave
Time frame: During post-lumbar puncture headache, up to 14 days after LP
Proportion with back pain
Time frame: Up to 14 days after LP
Proportion with radiating leg pain
Time frame: Up to 14 days after LP
Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
Time frame: Up to 14 days after LP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Background: PubMed 11061243Evans 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.
- Background: PubMed 19009898Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
- Background: PubMed 16116106Armon 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.
- Background: PubMed 9102578Strupp 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.
- Background: PubMed 21549395Hammond 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.
- Background: PubMed 11756618Strupp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sprotte 25G needle, stylet reinserted, Sprotte 25G needle, stylet not reinserted and Sprotte 22G needle, stylet reinserted in people with Post-Lumbar Puncture Headache, run by Jonatan Salzer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratio for post-lumbar puncture headache (any) (time frame: Up to 14 days after LP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960749, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 27 Oct 2026.