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

Not Applicable

Completed

• Conditions: Low Back Pain; Failed Back Surgery Syndrome; Radiculopathy; Epidural Fibrosis
• Interventions: Procedure: Caudal epidural steroid injection; Procedure: Transforaminal epidural steroid injection

• Registration Number: NCT05099796
• Lead Sponsor: Marmara University

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

Study Timeline

• Study Start: 2016-01-05
• Primary Completion: 2021-05-11
• Study Completion: 2021-05-11
• Status Verified: 2021-10
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal epidural steroid injection (CESI) group	Caudal epidural steroid injection	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.
Transforaminal epidural steroid injection (TESI) group	Transforaminal epidural steroid injection	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.

Primary Outcome Measures

Name	Time	Method
Change in pain severity	All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)	Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Change in disability score	All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)	Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.

Trial Locations

Locations (1)

Marmara University Pendik Training and Research Hospital; 🇹🇷 Istanbul, Turkey