Low Back Pain Due to Spinal Nerve CompressionNCT02281227
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
A study testing skin compression in people with Low Back Pain Due to Spinal Nerve Compression, run by Yonsei University at 1 site in South Korea.
Trial summary
To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Low Back Pain Due to Spinal Nerve Compression
- What is being tested?
- skin compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2014to 10 Oct 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 with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection
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
To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients
- Being tested
- skin compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin compressionProcedure or surgery
skin compression with an indicator for determination of needle entry point
| Study group | Role | What they receive |
|---|---|---|
| compression group | Active comparator | skin compression with an indicator for determination of needle entry point Receives: Procedure: skin compression |
| non-compression group | Active comparator | non skin compression with an indicator for determination of needle entry point Receives: Procedure: skin compression |
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 posted3 Nov 2014 (estimated)
- Study start20 Oct 2014
- Primary completion10 Oct 2015
- Study completion10 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT02281227
- Sponsor's protocol ID
- 4-2014-0721
- Status last verified
- Feb 2019
- First submitted
- 23 Oct 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients
- ClinicalTrials.gov ID
- NCT02281227
- Acronym / sponsor ID
- 4-2014-0721
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 10 Oct 2015 (actual)
- Study completion
- 10 Oct 2015 (actual)
- First posted
- 3 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.
To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compression group | Active comparator | Procedure: skin compressionskin compression with an indicator for determination of needle entry point |
| non-compression group | Active comparator | Procedure: skin compressionnon skin compression with an indicator for determination of needle entry point |
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 with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection
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 |
|---|---|---|
| skin compressionskin compression with an indicator for determination of needle entry point | Procedure or surgery | compression group, non-compression 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 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 Feb 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 skin compression in people with Low Back Pain 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 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 22 Feb 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?
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 Feb 2019.