Skip to main content
. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

Prager 1996.

Methods

  • Design: parallel‐group (2 arms + 1 in separated patients)

  • Country: USA

  • Multisite: no

  • Needle type design used: diamond vs pencil

  • Number of attempts: unknown

  • Procedure: myelography

  • Site of the puncture: L2‐3

  • Training level of those who administered the puncture: senior neuroradiologists

  • Median or paramedian technique: slightly off midline for most patients

  • Amount of CSF extracted: not collected

  • Amount of injected volume: iohexol (Omnipaque: Nycomed, New York, NY) (10 ml to 15 ml of 180 concentration for the lumbar spine and 10 ml of 300 concentration for the cervical spine)

  • Patient position: prone and slightly oblique on a fluoroscopy table with a pillow under the abdomen
Participants 1. 108 patients enrolled (patients referred for myelograms)
Exclusion criteria: inability to sit or stand, inability to reliably communicate, a situation that would tend to decrease the presence and reporting of spinal headache
108 patients randomized to:

  • Quincke group: 56 patients (51.85%)

  • Sprotte group: 52 patients (48.14%)


2. Main characteristics of patients:

  • Mean age:

    • Quincke: 57

    • Sprotte: 56

    • Gertie Marx: 57

  • Number of females/males: Gertie Marx: 13/17. Numbers not reported for the other groups.
Interventions

  1. Quincke group: 22 G bevel tip needle (Becton‐Dickinson, Franklin Lakes, NJ)

  2. Sprotte group: 22 G, pencil point (Pajunk, Geisingen, Germany)

  3. Co‐interventions: after myelogram bed rest with head of bed elevated 45 degrees for 6 hours after the procedure
Outcomes Outcomes were not classified as primary or secondary

  1. Incidence of PDPH

  2. Severity of PDPH (1 to 10 scale)

  3. Blood patches required: Quincke 2, Sprotte 2

  4. Non‐spinal headache

  5. Extraarachnoid contrast material
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: not reported

  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: "108 were randomized to a 22‐gauge" (page 1290)
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 Low risk Quote: "An observer contacted each subject by telephone 5‐14 days after the myelogram. The observer did not know which type of needle had been used on the subjects." (page 1290)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No 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