Lumbar Spinal StenosisNCT03867630
The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty
An observational study of Lumbar Spinal Stenosis, run by Ajou University School of Medicine.
Trial summary
Percutaneous epidural neuroplasty (PEN) is an effective interventional treatment for radicular pain. But in some cases with wire catheter like Racz catheter, contrast runoffs were not shown to the foramen. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Transforaminal Block
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2019to 30 Jun 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Medical records will be reviewed retrospectively about 100 patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections. As the next stage of treatment, percutaneous epidural neuroplasty with a wire type catheter is performed. The patient's symptoms, neurological examination, and imaging studies were evaluated to make a diagnosis. Patients 20 to 80 years old with a herniated disc, spinal stenosis are included. Percutaneous epidural neuroplasty using a wire type catheter was done, and patients had regular follow-up visits until 1 months after the neuroplasty.
Who may be able to join
- 20 to 80 years old
- Patients with a herniated disc, spinal stenosis
- Patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections
- Patients who are performed percutaneous epidural neuroplasty with wire type catheter.
Who cannot join
- Incomplete medical record
- Contraindication to percutaneous epidural neuroplasty
About this study
Official title: The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty With Wire Type Catheter in Lumbar Foraminal Stenosis Patients
Percutaneous epidural neuroplasty (PEN) is an effective interventional treatment for radicular pain. But in some cases with wire catheter like Racz catheter, contrast runoffs were not shown to the foramen. This study will show that contrast runoff will affect the results of PEN and in cases which contrast runoff are not shown, additional transforaminal epidural blocks will affect the results of PEN by reviewing medical record, retrospectively.
Read the detailed description
Medical records will be investigated in cases of PEN with wire type catheter from May 2016 to August 2018. About one hundred cases will be enrolled. Analysis will be performed. It will be compared 1) Success rate of Runoff group and Nonrunoff group in lumbar spine, 2) Success rate of Runoff group and Nonrunoff-NonTransforaminal group in lumbar spine. 3) Success rate of Runoff group with nonrunoff-transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine. 4) Success rate of Nonrunoff-Transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Transforaminal Block
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal BlockProcedure or surgery
Epidural block via neural foramen of lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| Runoff Group | Runoff group are the patients whose images were shown root shadow by contrast media. | |
| Nonrunoff-Transforaminal group | Nonrunoff-Transforaminal group are the patients whose images are not shown root shadows by contrast media, so additional transforaminal blocks are done. Receives: Procedure: Transforaminal Block | |
| Nonrunoff-NonTransforaminla group | Nonrunoff-NonTransforaminal group are the patients whose images are not shown root shadows by contrast media, but no additional transforaminal blocks are done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of three groups
Success rate of three groups(Runoff group, Nonrunoff-foraminal group, Nonrunoff-Nonforaminal group) will be compared each other. Success is defined as a 50% or greater reduction in pain score on the pre-procedural Visual Analogue Scale(VAS) score.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start10 May 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Bum Choi, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867630
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-554
- Status last verified
- May 2019
- First submitted
- 5 Mar 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gil HY, Lee SY, Min SK, Kim JE, Lee HS, Jeong HW, Park B, Choung J, Choi JB. The effect of additional transforaminal epidural blocks on percutaneous epidural neuroplasty with a wire-type catheter: A retrospective observational study. Medicine (Baltimore). 2019 Dec;98(50):e18233. doi: 10.1097/MD.0000000000018233.
PubMed 31852086
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty With Wire Type Catheter in Lumbar Foraminal Stenosis Patients
- ClinicalTrials.gov ID
- NCT03867630
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-554
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 10 May 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 8 Mar 2019 (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.
Percutaneous epidural neuroplasty (PEN) is an effective interventional treatment for radicular pain. But in some cases with wire catheter like Racz catheter, contrast runoffs were not shown to the foramen. This study will show that contrast runoff will affect the results of PEN and in cases which contrast runoff are not shown, additional transforaminal epidural blocks will affect the results of PEN by reviewing medical record, retrospectively.
Detailed description
Medical records will be investigated in cases of PEN with wire type catheter from May 2016 to August 2018. About one hundred cases will be enrolled. Analysis will be performed. It will be compared 1) Success rate of Runoff group and Nonrunoff group in lumbar spine, 2) Success rate of Runoff group and Nonrunoff-NonTransforaminal group in lumbar spine. 3) Success rate of Runoff group with nonrunoff-transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine. 4) Success rate of Nonrunoff-Transforaminal group and Nonrunoff-NonTransforaminal group in lumbar spine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Runoff Group | – | –Runoff group are the patients whose images were shown root shadow by contrast media. |
| Nonrunoff-Transforaminal group | – | Procedure: Transforaminal BlockNonrunoff-Transforaminal group are the patients whose images are not shown root shadows by contrast media, so additional transforaminal blocks are done. |
| Nonrunoff-NonTransforaminla group | – | –Nonrunoff-NonTransforaminal group are the patients whose images are not shown root shadows by contrast media, but no additional transforaminal blocks are done. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Medical records will be reviewed retrospectively about 100 patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections. As the next stage of treatment, percutaneous epidural neuroplasty with a wire type catheter is performed. The patient's symptoms, neurological examination, and imaging studies were evaluated to make a diagnosis. Patients 20 to 80 years old with a herniated disc, spinal stenosis are included. Percutaneous epidural neuroplasty using a wire type catheter was done, and patients had regular follow-up visits until 1 months after the neuroplasty.
Key inclusion criteria (4 listed)
- 20 to 80 years old
- Patients with a herniated disc, spinal stenosis
- Patients with chronic low back pain and lower extremity pain who did not respond to lumbar epidural steroid injections
- Patients who are performed percutaneous epidural neuroplasty with wire type catheter.
Key exclusion criteria (2 listed)
- Incomplete medical record
- Contraindication to percutaneous epidural neuroplasty
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 |
|---|---|---|
| Transforaminal BlockEpidural block via neural foramen of lumbar spine | Procedure or surgery | Nonrunoff-Transforaminal group |
Primary outcome
Success rate of three groups
Time frame: 1 month
Success rate of three groups(Runoff group, Nonrunoff-foraminal group, Nonrunoff-Nonforaminal group) will be compared each other. Success is defined as a 50% or greater reduction in pain score on the pre-procedural Visual Analogue Scale(VAS) score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 31852086Gil HY, Lee SY, Min SK, Kim JE, Lee HS, Jeong HW, Park B, Choung J, Choi JB. The effect of additional transforaminal epidural blocks on percutaneous epidural neuroplasty with a wire-type catheter: A retrospective observational study. Medicine (Baltimore). 2019 Dec;98(50):e18233. doi: 10.1097/MD.0000000000018233.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Ajou University School of Medicine.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Success rate of three groups (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03867630, which also lists 1 linked publication.
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 13 May 2019.