The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty
May 10, 2019 updated by: Jong Bum Choi, Ajou University School of Medicine
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Incomplete medical record
- Contraindication to percutaneous epidural neuroplasty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Epidural block via neural foramen of lumbar spine
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 10, 2019
Primary Completion (Anticipated)
June 30, 2019
Study Completion (Anticipated)
June 30, 2019
Study Registration Dates
First Submitted
March 5, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (Actual)
March 8, 2019
Study Record Updates
Last Update Posted (Actual)
May 13, 2019
Last Update Submitted That Met QC Criteria
May 10, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJIRB-MED-OBS-18-554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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