Lumbar Radiculopathy Due to Spinal Nerve CompressionNCT03341182
The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
A study testing Fluoroscopically Guided Lumbar Transforaminal Epidural Injections and conventional manner in people with Lumbar Radiculopathy Due to Spinal Nerve Compression, run by Yonsei University at 1 site in South Korea.
Trial summary
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbar Radiculopathy Due to Spinal Nerve Compression
- What is being tested?
- Fluoroscopically Guided Lumbar Transforaminal Epidural Injections and conventional manner
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2017to 21 Aug 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
- 1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.
Who cannot join
- Blood clotting disorder
- Infection around the site
- Contrast agent allergy
- Uncontrolled cardiovascular, cerebrovascular, kidney disease
- Past history of spinal surgery (ex, spinal fusion)
- If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
- Patients taking narcotic analgesics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
About this study
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain.
Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.
Read the detailed description
- A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
- This study is single-blind because it is not possible to blind the practitioner performing the injection.
- Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
- After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time
- Being tested
- Fluoroscopically Guided Lumbar Transforaminal Epidural Injections, conventional manner
- Keywords
- epidural steroid injection, radiation exposure, mirror
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopically Guided Lumbar Transforaminal Epidural InjectionsProcedure or surgery
Lay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views.
conventional mannerProcedure or surgery
A portable mirror is located at the side of surgical table and used in this procedure.
| Study group | Role | What they receive |
|---|---|---|
| normal method group (group A) | Active comparator | A mirror is not used in tunnel view technique (conventional manner) Receives: Procedure: conventional manner |
| mirror use group (group B) | Experimental | A mirror is used in tunnel view technique Receives: Procedure: Fluoroscopically Guided Lumbar Transforaminal Epidural Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation exposure time(second)
In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start21 Dec 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Radiculopathy Due to Spinal Nerve CompressionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- normal method group (group A) mirror use group (group B)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT03341182
- Sponsor's protocol ID
- 4-2017-0801
- Status last verified
- Jan 2019
- First submitted
- 25 Oct 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
- ClinicalTrials.gov ID
- NCT03341182
- Acronym / sponsor ID
- 4-2017-0801
- Keywords
- epidural steroid injection, radiation exposure, mirror
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 14 Nov 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.
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain.
Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.
Detailed description
- A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.
- This study is single-blind because it is not possible to blind the practitioner performing the injection.
- Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.
- After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- normal method group (group A) mirror use group (group B)
| Arm | Type | Receives |
|---|---|---|
| normal method group (group A) | Active comparator | Procedure: conventional mannerA mirror is not used in tunnel view technique (conventional manner) |
| mirror use group (group B) | Experimental | Procedure: Fluoroscopically Guided Lumbar Transforaminal Epidural InjectionsA mirror is used in tunnel view technique |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.
Key exclusion criteria (7 listed)
- Blood clotting disorder
- Infection around the site
- Contrast agent allergy
- Uncontrolled cardiovascular, cerebrovascular, kidney disease
- Past history of spinal surgery (ex, spinal fusion)
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 |
|---|---|---|
| Fluoroscopically Guided Lumbar Transforaminal Epidural InjectionsLay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views. | Procedure or surgery | mirror use group (group B) |
| conventional mannerA portable mirror is located at the side of surgical table and used in this procedure. | Procedure or surgery | normal method group (group A) |
Primary outcome
radiation exposure time(second)
Time frame: Immediately after the procedure
In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.
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 22 Jan 2019.
- Individual participant dataSharing planned: No
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 Fluoroscopically Guided Lumbar Transforaminal Epidural Injections and conventional manner in people with Lumbar Radiculopathy Due to Spinal Nerve Compression, 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 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 22 Jan 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 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 exposure time(second) (time frame: Immediately after the 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 22 Jan 2019.