Clinical trial NCT03867630: The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty
Official title: The Effect of Additional Transforaminal Epidural Blocks in Percutaneous Epidural Neuroplasty With Wire Type Catheter in Lumbar Foraminal Stenosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of three groups
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.