Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy

Marmara University

Status: Completed

Conditions: Epidural Fibrosis; Radiculopathy; Low Back Pain; Failed Back Surgery Syndrome

Treatments: Procedure: Caudal epidural steroid injection; Procedure: Transforaminal epidural steroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05099796

09.2014.0085

Details and patient eligibility

About

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

Full 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

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

62 participants in 2 patient groups

Transforaminal epidural steroid injection (TESI) group

Active Comparator group

Description:

This procedure was applied only once. 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected.

Treatment:

Procedure: Transforaminal epidural steroid injection

Caudal epidural steroid injection (CESI) group

Active Comparator group

Description:

This procedure was applied only once 1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI.

Treatment:

Procedure: Caudal epidural steroid injection