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. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

Strupp 2001.

Methods

  • Design: prospective, randomized, double‐blind study, 2 arms

  • Country: Germany

  • Multisite: no

  • Needle type design used: diamond vs pencil

  • Needle diameter used: 22 G (0.80 mm)

  • Number of attempts: not reported

  • Procedure: lumbar puncture

  • Site of the puncture: not reported

  • Training level of those who administered the puncture: experienced neurologists

  • Median or paramedian technique: not reported

  • Type of anaesthetic: not reported

  • Patient position: sitting
Participants 1. 230 patients enrolled (who had a neurologic indication for an LP (e.g. MS, neuroborreliosis or other CNS infections), between 18 and 59 years, no recent headache (at least up to 1 week before LP, years; 2) no recent headache, i.e. at least up to 1 week), no evidence of increased intracranial pressure, no LP in the last 4 weeks, ability to be mobilized and no previous headache or other pain medication.
Patients randomized to:

  • 22 G Sprotte (115)

  • 22 G Quincke (115)


2. No exclusions or loses to follow‐up were reported
3. Main characteristics of patients:

  • 22 G Sprotte: mean age 39.8 (SD 12.8), 64 females

  • 22 G Quincke: mean age 40.7 (SD 11.5), 63 females
Interventions

  1. "atraumatic" Sprotte needle (22 G, 0.80 mm, 90 mm; Pajunk, Geisingen, Germany)

  2. "traumatic" Quincke needle (22 G, 0.80 mm, 90 mm; Braun, Melsungen, Germany)
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. PDPH intensity (mean pain score)

  3. PDPH severity
Notes

  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: no

  5. Conducted: November 2000 to March 2001

  6. Declared conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "Patients were allocated randomly to one or the other group according to Efron." (page 2311)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear if patients were lost to follow‐up
Selective reporting (reporting bias) High risk Adverse events, additional to PDPH, were not reported
Other bias Low risk No other biases were identified