The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty

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: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Transforaminal Block

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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

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.	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

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Publications and helpful links

General 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.

Study record dates

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: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• 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