Lumbosacral Radicular PainNCT02867046
The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View
A study testing S1 transforaminal epidural steroid(dexamethasone) injection in people with Lumbosacral Radicular Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbosacral Radicular Pain
- What is being tested?
- S1 transforaminal epidural steroid(dexamethasone) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2016to 28 Nov 2016
- 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. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic
Who cannot join
- pregnancy
- coagulopathy
- systemic infection
- any active infection at the injection site
- history of allergy to contrast media, local anesthetics, corticosteroid
- patients unable to communicate or patients with cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.
- Conditions
- Lumbosacral Radicular Pain
- Being tested
- S1 transforaminal epidural steroid(dexamethasone) injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1 transforaminal epidural steroid(dexamethasone) injectionDrug
medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy
lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen
| Study group | Role | What they receive |
|---|---|---|
| medial approach group | Experimental | Not described Receives: Drug: S1 transforaminal epidural steroid(dexamethasone) injection |
| lateral approach group | Active comparator | Not described Receives: Drug: S1 transforaminal epidural steroid(dexamethasone) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of intravascular injection in the medial approach group in S1 foramen
Measured: 5 seconds after injection of contrast media via block needle.
the incidence of intravascular injection in the lateral approach group in S1 foramen
Measured: 5 seconds after injection of contrast media via block needle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start29 Jul 2016
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Radicular PainStudies 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
- 165 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
- NCT02867046
- Sponsor's protocol ID
- 4-2016-0442
- Status last verified
- May 2018
- First submitted
- 7 Aug 2016
- Last updated
- 18 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View
- ClinicalTrials.gov ID
- NCT02867046
- Acronym / sponsor ID
- 4-2016-0442
- Conditions
- Lumbosacral Radicular Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 15 Aug 2016 (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.
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medial approach group | Experimental | Drug: S1 transforaminal epidural steroid(dexamethasone) injection |
| lateral approach group | Active comparator | Drug: S1 transforaminal epidural steroid(dexamethasone) injection |
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. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic
Key exclusion criteria (6 listed)
- pregnancy
- coagulopathy
- systemic infection
- any active infection at the injection site
- history of allergy to contrast media, local anesthetics, corticosteroid
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 |
|---|---|---|
| S1 transforaminal epidural steroid(dexamethasone) injectionmedial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen | Drug | lateral approach group, medial approach group |
Primary outcome
the incidence of intravascular injection in the medial approach group in S1 foramen
Time frame: 5 seconds after injection of contrast media via block needle.
the incidence of intravascular injection in the lateral approach group in S1 foramen
Time frame: 5 seconds after injection of contrast media via block needle.
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 May 2018.
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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.
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 S1 transforaminal epidural steroid(dexamethasone) injection in people with Lumbosacral Radicular Pain, 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 6 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 May 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?
the incidence of intravascular injection in the medial approach group in S1 foramen (time frame: 5 seconds after injection of contrast media via block needle.). The study lists 2 primary outcomes in all. 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 May 2018.