NCT01009385

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
Last Updated

November 6, 2009

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

November 4, 2009

Last Update Submit

November 5, 2009

Conditions

Head PainNeck PainUpper Extremity Pain

Keywords

cervicalepiduralepidural pressuremonitoring

Outcome Measures

Primary Outcomes (1)

  • cervical epidural pressure

    on interventional procedure (cervical epidural steroid injetion)

Secondary Outcomes (1)

  • the angle of the neck flexion

    on interventional procedure (cervical epidural steroid injection)

Study Arms (2)

prone position

ACTIVE COMPARATOR
Procedure: cervical epidural steroid injectionProcedure: epidural pressure measurement

sitting position

ACTIVE COMPARATOR
Procedure: cervical epidural steroid injectionProcedure: epidural pressure measurement

Interventions

cervical epidural steroid injectionPROCEDURE

* 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
prone positionsitting position
epidural pressure measurementPROCEDURE

* 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
prone positionsitting position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Kŭmi, Kyonggi-do, 463-707, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 24658476DERIVED

  • 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.

    PMID: 20693880DERIVED

MeSH Terms

Conditions

HeadacheNeck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeeyoun Moon

    Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 6, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 6, 2009

Record last verified: 2009-11

Locations

KR(1)