Analysis, Event HistoryNCT02838654
Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit
An observational study of Analysis, Event History, run by Keimyung University Dongsan Medical Center.
Trial summary
The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Analysis, Event History
- What is being tested?
- cervical epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who complain chronic neck pain due to cervical spinal disease or acute herpes zoster
Who may be able to join
- Cerivical Herniated nucleusus
- Cerivical spinal stenosis
- acute herpes zoster
Who cannot join
- Coagulopathy
- Infectious cervical disease
- Pregnancy
About this study
Official title: Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks
The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.
Read the detailed description
The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.
Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.
Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.
- Conditions
- Analysis, Event History
- Being tested
- cervical epidural injection
- Keywords
- cervical epidural space, wave form analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical epidural injectionProcedure or surgery
sensitivity, specificity, positive predictive value, negative predictive value
| Study group | Role | What they receive |
|---|---|---|
| cervical epidural injection group | cervical epidural injection group Receives: Procedure: cervical epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidural wave form reliability (sensitivity, specificity) analysis
Measured: 1 minute after the completion of the epidural injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analysis, Event HistoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
- Investigators
- JiHEE Hong, MD, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838654
- Sponsor's protocol ID
- 2016-05-037
- Status last verified
- Nov 2017
- First submitted
- 12 Jul 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks
- ClinicalTrials.gov ID
- NCT02838654
- Acronym / sponsor ID
- 2016-05-037
- Conditions
- Analysis, Event History
- Keywords
- cervical epidural space, wave form analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.
Detailed description
The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.
Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.
Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cervical epidural injection group | – | Procedure: cervical epidural injectioncervical epidural injection group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who complain chronic neck pain due to cervical spinal disease or acute herpes zoster
Key inclusion criteria (3 listed)
- Cerivical Herniated nucleusus
- Cerivical spinal stenosis
- acute herpes zoster
Key exclusion criteria (3 listed)
- Coagulopathy
- Infectious cervical disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical epidural injectionsensitivity, specificity, positive predictive value, negative predictive value | Procedure or surgery | cervical epidural injection group |
Primary outcome
epidural wave form reliability (sensitivity, specificity) analysis
Time frame: 1 minute after the completion of the epidural injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JiHEE Hong, MD, PhD principal investigator
Keimyung University
Questions about this trial
What is this clinical trial studying?
An observational study of Analysis, Event History, run by Keimyung University Dongsan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidural wave form reliability (sensitivity, specificity) analysis (time frame: 1 minute after the completion of the epidural injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.