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Status unknownNCT01009385Updated Nov 6, 2009

Cervical Epidural Pressure Measurement

An interventional study of cervical epidural steroid injection and epidural pressure measurement in Head Pain, Neck Pain and Upper Extremity Pain, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-11-06.

Sponsored by Seoul National University Bundang Hospital · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Cervical epidural steroid injections

  • The hanging drop (HD) technique is commonly used for identifying the cervical epidural space.
  • The hanging drop (HD) technique is using the negative pressure in the epidural space.
  • The subject of debate whether the epidural space exhibits negative pressure.
  • In a previous study, EP might be influenced by body position
  • No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.

The hypothesis of this study

  • There is a difference in the cervical epidural pressure between in the prone and sitting positions
  • To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
  • Using a closed pressure measurement system
  • Under fluoroscopic guidance.
Read the detailed description

Cervical epidural steroid injections (CESIs)

  • For the conservative management of head, neck, and upper extremity pain
  • Important to identify the epidural space for minimizing the chance of a dural puncture injection
  • Dural puncture injection makes CESIs prone to rare but catastrophic complication like permanent spinal cord injury

The hanging drop (HD) technique

  • Commonly used for identifying the cervical epidural space
  • Using the negative pressure in the epidural space
  • The subject of debate whether the epidural space exhibits negative pressure

In previous studies using a closed pressure measurement systems

  • The epidural pressure (EP) was commonly positive at the thoracic level in the lateral decubitus position.
  • EP was consistently negative only in the sitting position.
  • EP might be influenced by body position.
  • The patient should be sitting for using the HD technique.

No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.

The hypothesis of this study

  • There is a difference in the cervical epidural pressure between in the prone and sitting positions
  • To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
  • Using a closed pressure measurement system
  • Under fluoroscopic guidance.
02

Conditions studied

  • Head Pain
  • Neck Pain
  • Upper Extremity Pain

Keywords

  • cervical
  • epidural
  • epidural pressure
  • monitoring
03

In context

Headache

1,235 studies on the registry are indexed under Headache; 201 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 926 interventional studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.

Browse Seoul National University Bundang Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • cervical radicular pain caused by herniated nucleus pulpous and spinal stenosis
  • other conditions including herpes zoster-associated pain and sprain.

Exclusion criteria

Exclusion Criteria:

  • contraindications for CESIs, such as coagulopathy, patient refusal or infection at the proposed insertion site
  • previous cervical spinal surgery
  • pregnancy.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    prone position

    Procedure: cervical epidural steroid injection · Procedure: epidural pressure measurement

  • Active comparator
    sitting position

    Procedure: cervical epidural steroid injection · Procedure: epidural pressure measurement

Interventions

  • Procedurecervical epidural steroid injection

    * After aseptic preparation and skin infiltration with 1% lidocaine * 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level * identification of the epidural space confirmed by injection of contrast medium under fluoroscope * injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl). * Post-procedure, patients were observed for any adverse effects and followed with a neurological examination

    Also known as: cervical interlaminar epidural injection

  • Procedureepidural pressure measurement

    * The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view. * Identification of the epidural space and measurement of EP was performed with a closed measurement system.

    Also known as: a closed pressure measurement system

06

What researchers measure

Primary outcomes

  1. cervical epidural pressure

    Time frame: on interventional procedure (cervical epidural steroid injetion)

Secondary outcomes

  1. the angle of the neck flexion

    Time frame: on interventional procedure (cervical epidural steroid injection)

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Kumi, Kyonggi-do 463-707, South Korea
08

References and documents

Publications

  • Joo Y, Moon JY, Kim YC, Lee SC, Kim HY, Park SY. A pressure comparison between midline and paramedian approaches to the cervical epidural space. Pain Physician. 2014 Mar-Apr;17(2):155-62. PubMed 24658476 ↗
  • Moon JY, Lee PB, Nahm FS, Kim YC, Choi JB. Cervical epidural pressure measurement: comparison in the prone and sitting positions. Anesthesiology. 2010 Sep;113(3):666-71. doi: 10.1097/ALN.0b013e3181e898e8. PubMed 20693880 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Nov 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2009
First posted
Nov 6, 2009
Start
Oct 2009
Primary completionEst.
Nov 2009
CompletionEst.
Nov 2009
Last update
Nov 6, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01009385
Lead sponsor
Seoul National University Bundang Hospital
First posted
Nov 6, 2009
Start date
Oct 2009
Primary completion
Nov 2009 (estimated)
Completion
Nov 2009 (estimated)
Last update
Nov 6, 2009

Study contacts

Jeeyoun Moon
principal investigator · Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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