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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Transforaminal Block
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ajou University School of Medicine

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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