Clinical trial NCT05099796: Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
Official title: Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Low Back Pain
Radiculopathy
Epidural Fibrosis
Keywords: Failed back surgery syndrome, epidural steroid injections
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old

Detailed description: Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
* Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
* Having low back and leg pain for at least six months and unresponsive to conservative therapies
* A Numerical Rating Scale score of ≥4
* Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging

Exclusion Criteria:

* Having a multi-level epidural fibrosis
* Previous surgery for multi-level disc herniation
* Previous lumbar fusion surgery
* Having recurrent disc hernia
* Having sacroiliac/facet joint pain
* Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis
* History of epidural steroid injection within the past six months
* Having bleeding diathesis
* Presence of systemic or local infections
* Pregnancy
* Known hypersensitivity to the injectates to be applied

Primary outcomes:
measure: Change in pain severity
timeFrame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
measure: Change in disability score
timeFrame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
affiliation: Marmara University Pendik Training and Research Hospital
name: Savas Sencan, Assoc. Prof.
role: STUDY_DIRECTOR
References: