Analysis, Event HistoryNCT03245294
Factors Contributing to the Pressure Wave Form Changes
A study testing lumbar epidural injection in people with Analysis, Event History, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern. 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?
- lumbar epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 11 Apr 2018
- Phase
- Interventional
- 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
Who may be able to join
- lumbar herniated nucleus
- lumbar spinal stenosis
- internal disc disruption
- NRS > 5
- ODI > 20
Who cannot join
- coagulopathy
- allergy to contrast media
- infection at needle insertion site
- absence of lumbar MRI
- Pregnancy
- previous lumbar spine surgery
- neurological symptoms requiring prompt reevalution
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
The purpose of this study is to evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.
Read the detailed description
Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is felt through the sudden decrease of pressure and this pressure gradient is generated when the needle is within the passage of interspinous ligament, ligamentum flavum and epidural space. The presence of ligamentum flavum is crucial for the identification of epidural space by LOR. However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament can modify this passage and a false LOR is generated consequentially. The false positive rate of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the false positive rate is high, repeated attempts of epidural steroid injection (ESI) are required, with additional discomfort or pain to the patient.
The high rate of false LOR has prompted the design of adjunctive modalities. Among these, epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile wave coinciding with arterial pulsations can be seen through the monitor.
Recent study suggested that significant abrupt pressure decrease occurs when cervical epidural injection was done via paramedian approach rather than midline.
- Conditions
- Analysis, Event History
- Being tested
- lumbar epidural injection
- Keywords
- cervical epidural space, abrupt pressure decrease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar epidural injectionProcedure or surgery
the pattern of pressure decrease from ligamentum flavum to epidural space
| Study group | Role | What they receive |
|---|---|---|
| Lumbar ESI with paramedian approach | Active comparator | Lumbar ESI with paramedian approach Receives: Procedure: lumbar epidural injection |
| Lumbar ESI with midline approach | Active comparator | Lumbar ESI with midline approach Receives: Procedure: lumbar epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pattern of epidural pressure decrease
abrupt or gradual decrease of epidural pressure
Measured: 1 second after the completion of entry from ligamentum flavum to epidural space
Secondary outcomes (1)
factors contributing the epidural pressure pattern
factors contributing the epidural pressure decrease(abrupt vs. gradual) pattern
Measured: 60 minutes after the completion of entry from ligamentum flavum to epidural space
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Aug 2017
- Primary completion11 Apr 2018
- Study completion11 Apr 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 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
- Ji Hee Hong, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245294
- Sponsor's protocol ID
- 2017-05-039
- Status last verified
- Apr 2018
- First submitted
- 3 Aug 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Contributing to the Pressure Wave Form Changes During Lumbar Epidural Injections
- ClinicalTrials.gov ID
- NCT03245294
- Acronym / sponsor ID
- 2017-05-039
- Conditions
- Analysis, Event History
- Keywords
- cervical epidural space, abrupt pressure decrease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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 evaluate the decrease pattern of lumbar epidural pressure from ligamentum flavum to epidural space and analyzing factors contributing this pressure change pattern.
Detailed description
Loss of resistance (LOR) is the most commonly used method to confirm the epidural space. The advantage of LOR is its simplicity; only saline or air filled syringe is required. LOR is felt through the sudden decrease of pressure and this pressure gradient is generated when the needle is within the passage of interspinous ligament, ligamentum flavum and epidural space. The presence of ligamentum flavum is crucial for the identification of epidural space by LOR. However, gaps in ligamentum flavum, paravertebral muscle and cyst in interspinous ligament can modify this passage and a false LOR is generated consequentially. The false positive rate of the lumbar and cervical area was reported to be 8.3~17% and 30~68%, respectively. If the false positive rate is high, repeated attempts of epidural steroid injection (ESI) are required, with additional discomfort or pain to the patient.
The high rate of false LOR has prompted the design of adjunctive modalities. Among these, epidural pressure waveform analysis (EPWA) using pressure transducer has been reported. If the epidural needle or catheter is positioned accurately in the epidural space, a pulsatile wave coinciding with arterial pulsations can be seen through the monitor.
Recent study suggested that significant abrupt pressure decrease occurs when cervical epidural injection was done via paramedian approach rather than midline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar ESI with paramedian approach | Active comparator | Procedure: lumbar epidural injectionLumbar ESI with paramedian approach |
| Lumbar ESI with midline approach | Active comparator | Procedure: lumbar epidural injectionLumbar ESI with midline approach |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- lumbar herniated nucleus
- lumbar spinal stenosis
- internal disc disruption
- NRS > 5
- ODI > 20
Key exclusion criteria (7 listed)
- coagulopathy
- allergy to contrast media
- infection at needle insertion site
- absence of lumbar MRI
- 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 |
|---|---|---|
| lumbar epidural injectionthe pattern of pressure decrease from ligamentum flavum to epidural space | Procedure or surgery | Lumbar ESI with midline approach, Lumbar ESI with paramedian approach |
Primary outcome
pattern of epidural pressure decrease
Time frame: 1 second after the completion of entry from ligamentum flavum to epidural space
abrupt or gradual decrease of epidural pressure
1 secondary outcome
factors contributing the epidural pressure pattern
Time frame: 60 minutes after the completion of entry from ligamentum flavum to epidural space
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 17 Apr 2018.
- 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.
Ji Hee Hong, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar epidural injection in people with Analysis, Event History, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 5 inclusion and 7 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
pattern of epidural pressure decrease (time frame: 1 second after the completion of entry from ligamentum flavum to epidural space). 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 17 Apr 2018.