Intravascular InjectionNCT05362084
Intravascular Injection Incidences During Lumbar Medial Branch Block
A study testing lumbar medial branch block in people with Intravascular Injection, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Intravascular Injection
- What is being tested?
- lumbar medial branch block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2021to 30 Apr 2022
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- facet joint arthropathy
Who cannot join
- allergy to local anesthetics or contrast medium
- pregnancy
- spine deformity
- neurologic abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravascular Injection Incidences Durig Lumbar Medial Branch Block Using Anteroposterior or Oblique Angle
The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block
Read the detailed description
In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection demonstrated technical easiness and reduced intravascular injection incidences. For the procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are possible. Usually, which approach method to use is determined according to the physician's preferences.
The final target for lumbar medial branch block is the junction betweeen superior articular process and transverse process. This target can be easily confirmed under the scotty dog appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty dog appearance more visible so that physician can identify bony landmark more easily for lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide more advantages in identifying bony landmark. However, it is uncertain whether this approach can provide technicaL easiness and reduce the intravascualr injection incidences.
- Conditions
- Intravascular Injection
- Being tested
- lumbar medial branch block
- Keywords
- intravascular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar medial branch blockProcedure or surgery
lumbar medial branch block
| Study group | Role | What they receive |
|---|---|---|
| Oblique group | Active comparator | medial branch block with oblique group Receives: Procedure: lumbar medial branch block |
| Anteroposterior group | Placebo comparator | medial branch block with anteroposterior group Receives: Procedure: lumbar medial branch block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intravasuclar injection
incidence of intravasuclar injection
Measured: 1 minute after finishing lumbar medial branch block
Secondary outcomes (2)
time required to complete lumbar medial branch block
time required to complete lumbar medial branch block
Measured: 1 second after finishing lumbar medial branch block
radiation amount to complete lumbar medial branch block
radiation amount to complete lumbar medial branch block
Measured: 1 second after finishing lumbar medial branch block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start3 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular InjectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362084
- Sponsor's protocol ID
- 2021-07-014-002
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 23 May 2022
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Injection Incidences Durig Lumbar Medial Branch Block Using Anteroposterior or Oblique Angle
- ClinicalTrials.gov ID
- NCT05362084
- Acronym / sponsor ID
- 2021-07-014-002
- Conditions
- Intravascular Injection
- Keywords
- intravascular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 May 2022 (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.
The purpose of this study is to compare using oblique fluoroscopic angle has any advantage in reducing the incidence of vascular punture and technical easiness during lumbar medial branch block
Detailed description
In previous report, the use of oblique fluoroscopic angle during S1 transforaminal injection demonstrated technical easiness and reduced intravascular injection incidences. For the procedure lumbar medial branch block, both anteroposterior and oblique fluoroscopic angle are possible. Usually, which approach method to use is determined according to the physician's preferences.
The final target for lumbar medial branch block is the junction betweeen superior articular process and transverse process. This target can be easily confirmed under the scotty dog appearance. If we use oblique fluoroscopic angle, this approach (30 degree) can make scotty dog appearance more visible so that physician can identify bony landmark more easily for lumbar medial branch block. For beginners, oblique fluoroscopic approach seems to provide more advantages in identifying bony landmark. However, it is uncertain whether this approach can provide technicaL easiness and reduce the intravascualr injection incidences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oblique group | Active comparator | Procedure: lumbar medial branch blockmedial branch block with oblique group |
| Anteroposterior group | Placebo comparator | Procedure: lumbar medial branch blockmedial branch block with anteroposterior group |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- facet joint arthropathy
Key exclusion criteria (4 listed)
- allergy to local anesthetics or contrast medium
- pregnancy
- spine deformity
- neurologic abnormality
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 |
|---|---|---|
| lumbar medial branch blocklumbar medial branch block | Procedure or surgery | Anteroposterior group, Oblique group |
Primary outcome
incidence of intravasuclar injection
Time frame: 1 minute after finishing lumbar medial branch block
incidence of intravasuclar injection
2 secondary outcomes
time required to complete lumbar medial branch block
Time frame: 1 second after finishing lumbar medial branch block
radiation amount to complete lumbar medial branch block
Time frame: 1 second after finishing lumbar medial branch block
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 23 May 2022.
- Individual participant dataSharing planned: No
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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 lumbar medial branch block in people with Intravascular Injection, run by Keimyung University Dongsan Medical Center 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 4 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 23 May 2022. 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. Some participants in this study may receive a placebo. 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?
incidence of intravasuclar injection (time frame: 1 minute after finishing lumbar medial branch block). 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 23 May 2022.