Analgesia, EpiduralNCT04071483
Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis
A study testing Cervical transforaminal epidural steroid injection in people with Analgesia, Epidural, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Cervical transforaminal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
Who cannot join
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook national university hospital
Daegu, 700-412
Jimin Heo, 82-53-420-5430, knuhmrc@knu.ac.kr
About this study
Official title: Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study
This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection
Read the detailed description
Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.
The incidence of intravascular injection during CTFESI was known as 20.6% ~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.
To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.
Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.
- Conditions
- Analgesia, Epidural
- Being tested
- Cervical transforaminal epidural steroid injection
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical transforaminal epidural steroid injectionProcedure or surgery
Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
| Study group | Role | What they receive |
|---|---|---|
| Moderate stenosis | Experimental | Moderate cervical neural foraminal stenosis is narrowest width of the neural foramen was >50% of the width of the width of the extraforaminal nerve root at the level of the anterior margin of the superior articular process. Receives: Procedure: Cervical transforaminal epidural steroid injection |
| Severe stenosis | Active comparator | Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width Receives: Procedure: Cervical transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravascular injection
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
Measured: During procedure
Secondary outcomes (1)
Pain intensity
Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before treatment and at 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeyoung Kim, MD, PhD, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071483
- Sponsor's protocol ID
- 2018-06-009-001
- Status last verified
- Sep 2019
- First submitted
- 26 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study
- ClinicalTrials.gov ID
- NCT04071483
- Acronym / sponsor ID
- 2018-06-009-001
- Conditions
- Analgesia, Epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 28 Aug 2019 (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.
This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection
Detailed description
Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.
The incidence of intravascular injection during CTFESI was known as 20.6% ~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.
To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.
Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate stenosis | Experimental | Procedure: Cervical transforaminal epidural steroid injectionModerate cervical neural foraminal stenosis is narrowest width of the neural foramen was >50% of the width of the width of the extraforaminal nerve root at the level of the anterior margin of the superior articular process. |
| Severe stenosis | Active comparator | Procedure: Cervical transforaminal epidural steroid injectionSevere cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
Key exclusion criteria (1 listed)
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
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 transforaminal epidural steroid injectionCervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain. | Procedure or surgery | Moderate stenosis, Severe stenosis |
Primary outcome
Intravascular injection
Time frame: During procedure
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
1 secondary outcome
Pain intensity
Time frame: Before treatment and at 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical transforaminal epidural steroid injection in people with Analgesia, Epidural, run by Kyungpook National University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jimin Heo (+82-53-420-5430, knuhmrc@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravascular injection (time frame: During procedure). 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 9 Sep 2019.