Low Back Pain Requiring Epidural InjectionNCT02300714
Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach
A study testing oblique view approach in people with Low Back Pain Requiring Epidural Injection, run by Yonsei University at 1 site in South Korea.
Trial summary
A comparison of anterioposterior versus oblique view approach method for fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate differences on total radiation time and technical feasibility between anterioposterior and oblique view approach method. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Low Back Pain Requiring Epidural Injection
- What is being tested?
- oblique view approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to 14 Jul 2015
- 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
- Adult patients who were scheduled for the transforaminal epidural injection in midthoracic region (T5-T7)
Who cannot join
- Local anesthetic allergy, coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
A comparison of anterioposterior versus oblique view approach method for fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate differences on total radiation time and technical feasibility between anterioposterior and oblique view approach method.
- Being tested
- oblique view approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oblique view approachProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AP group | Active comparator | oblique view approach during transforaminal epidural block Receives: Procedure: oblique view approach |
| OB group | Active comparator | oblique view approach during transforaminal epidural block Receives: Procedure: oblique view approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radiation exposure time
Total radiation exposure time during whole epidural procedure.
Measured: immediately ≤1 sec after the confirmation of successful epidural injection
Secondary outcomes (1)
The number of the needle readjustments
The number of the needle readjustments for successful epidural injection
Measured: immediately ≤1 sec after the confirmation of successful epidural injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion14 Jul 2015
- Study completion14 Jul 2015
Why it stopped: Terminated due to lack of assistance and time to carry out the research.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain Requiring Epidural InjectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300714
- Sponsor's protocol ID
- 4-2014-0822
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2014
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopically-guided Epidural Block in the Midthoracic Region: A Comparison of Anterioposterior Versus Oblique View Approach
- ClinicalTrials.gov ID
- NCT02300714
- Acronym / sponsor ID
- 4-2014-0822
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of assistance and time to carry out the research.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 14 Jul 2015 (actual)
- Study completion
- 14 Jul 2015 (actual)
- First posted
- 25 Nov 2014 (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.
A comparison of anterioposterior versus oblique view approach method for fluoroscopically-guided epidural block in the midthoracic region. The investigators evaluate differences on total radiation time and technical feasibility between anterioposterior and oblique view approach method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP group | Active comparator | Procedure: oblique view approachoblique view approach during transforaminal epidural block |
| OB group | Active comparator | Procedure: oblique view approachoblique view approach during transforaminal epidural block |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who were scheduled for the transforaminal epidural injection in midthoracic region (T5-T7)
Key exclusion criteria (1 listed)
- Local anesthetic allergy, coagulopathy
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 |
|---|---|---|
| oblique view approach | Procedure or surgery | AP group, OB group |
Primary outcome
Total radiation exposure time
Time frame: immediately ≤1 sec after the confirmation of successful epidural injection
Total radiation exposure time during whole epidural procedure.
1 secondary outcome
The number of the needle readjustments
Time frame: immediately ≤1 sec after the confirmation of successful epidural injection
Results and safety
The study was stopped early (reason given: Terminated due to lack of assistance and time to carry out the research.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oblique view approach in people with Low Back Pain Requiring Epidural Injection, run by Yonsei University 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: stopped early, as of the sponsor's last update on 22 Mar 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?
The study was stopped early (reason given: Terminated due to lack of assistance and time to carry out the research.). Results are not available in the source record.
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?
Total radiation exposure time (time frame: immediately ≤1 sec after the confirmation of successful 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 22 Mar 2019.