The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty

Lumbar Spinal Stenosis Clinical Trial

Official title:

The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty With Wire Type Catheter in Lumbar Foraminal Stenosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03867630
• Other study ID #: AJIRB-MED-OBS-18-554
• Status: Not yet recruiting
• Start date: May 10, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2019
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Transforaminal Block
Epidural block via neural foramen of lumbar spine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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