Cervical Epidural Pressure Measurement

Not Applicable

• Conditions: Head Pain; Upper Extremity Pain; Neck Pain
• Interventions: Procedure: cervical epidural steroid injection; Procedure: epidural pressure measurement

• Registration Number: NCT01009385
• Lead Sponsor: Seoul National University Bundang Hospital

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.

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.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-04
• Study First Submitted QC: 2009-11-05
• Last Update Submitted: 2009-11-05
• Study First Posted: 2009-11-06
• Last Update Posted: 2009-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prone position	epidural pressure measurement	-
sitting position	cervical epidural steroid injection	-
prone position	cervical epidural steroid injection	-
sitting position	epidural pressure measurement	-

Primary Outcome Measures

Name	Time	Method
cervical epidural pressure	on interventional procedure (cervical epidural steroid injetion)

Secondary Outcome Measures

Name	Time	Method
the angle of the neck flexion	on interventional procedure (cervical epidural steroid injection)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Kumi, Kyonggi-do, Korea, Republic of