Low Back PainPhase 3NCT01751958
Radiation Exposure in Spine Intervention Under Angiography
A Phase 3 study testing Epidural steroid injection in people with Low Back Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- 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
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Mar 2012
- Phase
- Phase 3
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suspected of having radiculopathic low back pain
Who cannot join
- Angiography is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI
Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI
Read the detailed description
The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.
- Conditions
- Low Back Pain
- Being tested
- Epidural steroid injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural steroid injectionRadiation
Epidural steroid injection
| Study group | Role | What they receive |
|---|---|---|
| Epidural Steroid injection | Experimental | Group-Epidural Steroid injection (Intermittent) Receives: Radiation: Epidural steroid injection |
| Epidural Steroid Injection2 | Experimental | Group-injection under angiography (continuous) Receives: Radiation: Epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose
Radiation dose of patients with spine invervention under angiography
Measured: Treatment on the day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suyoung Kim, Seoul National University Bundang Hospital
- Investigators
- Joon-woo Lee, MD,PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751958
- Sponsor's protocol ID
- B-1105/128-014
- Status last verified
- Dec 2012
- First submitted
- 13 Dec 2012
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI
- ClinicalTrials.gov ID
- NCT01751958
- Acronym / sponsor ID
- B-1105/128-014
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 18 Dec 2012 (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.
Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI
Detailed description
The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Steroid injection | Experimental | Radiation: Epidural steroid injectionGroup-Epidural Steroid injection (Intermittent) |
| Epidural Steroid Injection2 | Experimental | Radiation: Epidural steroid injectionGroup-injection under angiography (continuous) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected of having radiculopathic low back pain
Key exclusion criteria (1 listed)
- Angiography is contraindicated
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 |
|---|---|---|
| Epidural steroid injectionEpidural steroid injection | Radiation | Epidural Steroid Injection2, Epidural Steroid injection |
Primary outcome
Radiation dose
Time frame: Treatment on the day
Radiation dose of patients with spine invervention under angiography
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 18 Dec 2012.
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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.
Joon-woo Lee, MD,PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epidural steroid injection in people with Low Back Pain, run by Seoul National University Bundang 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: finished, as of the sponsor's last update on 18 Dec 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radiation dose (time frame: Treatment on the day). 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 18 Dec 2012; AzTrials last refreshed its copy on 3 Nov 2026.