A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

May 24, 2011 updated by: Seoul National University Bundang Hospital

Advantages of the Paramedian Approach for Cervical Epidural Steroid Injections: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

Ligamentum flavum in the cervical region is thin or not fused at the midline. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ligamentum flavum in the cervical region is thin or not fused at the midline. The distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (LOR) technique may be blunted or even absent. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs). Therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. Then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during CESIs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jee Youn . Moon, M.D.
  • Phone Number: 82-2-2072-2467 82-10-5299-2036
  • Email: jymoon0901@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Jee Youn Moon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 to 80 yr
  • Cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months
  • Pain intensity > 4 of maximum 10 NRS
  • Failure to improve with conservative treatment
  • Cervical epidural location of needle confirmed by the fluoroscopic images

Exclusion Criteria:

  • Acute infection
  • Patient refusal
  • Previous cervical spine surgery
  • Structural spinal deformities or A space-occupying epidural mass
  • Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation
  • Pregnancy
  • Allergy to contrast media or drugs to be used in the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: midline approach
cervical epidural steroid injection with 18G Touhy epidural needle by midline approach
Procedure: Cervical epidural steroid injection
cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)
Active Comparator: paramedian approach
cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach
Procedure: Cervical epidural steroid injection
cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
precipitous decrease
Time Frame: It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)
It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
popping sensation
Time Frame: It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Existence of the tactile sensation of give by pain experts (exist or not)
It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
spreading levels of dye according to dye volume
Time Frame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Dye Volume / Dye Spreading Level after injection of 0.5 cc contrast dye, then check the spreading level such as the number of vertebral body and unilateral or bilateral spreading
It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
cervical epidural pressure
Time Frame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
The bevel of the needle is considered to have entered the epidural space when a typical waveform is observed, which consists of small cardiac oscillations superimposed on greater respiratory oscillations. The needle is then held immobile in the epidural space for 120 s to allow the epidural pressure to stabilize, and CEP is measured.
It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Bundang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • jymoon0901

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