The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty

NCT03867630 | Unknown

• 1 other identifier: AJIRB-MED-OBS-18-554
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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.

Interventions

Transforaminal Block PROCEDURE

Epidural block via neural foramen of lumbar spine

Nonrunoff-Transforaminal group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Incomplete medical record
• Contraindication to percutaneous epidural neuroplasty

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Related Publications (1)

• 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.

  PMID: 31852086 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 8, 2019
• Study Start: May 10, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share