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

Study Overview
=================
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

Official Title
-----------------
Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial

Conditions
-----------------
Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy, Epidural Fibrosis

Intervention / Treatment
-----------------
* Procedure: Transforaminal epidural steroid injection
* Procedure: Caudal epidural steroid injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transforaminal epidural steroid injection (TESI) group<br>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. | Procedure: Transforaminal epidural steroid injection<br> <br> |
| Active Comparator: Caudal epidural steroid injection (CESI) group<br>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. | Procedure: Caudal epidural steroid injection<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity | 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). | All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure) | 
| Change in disability score | 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. | All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Failed back surgery syndrome, epidural steroid injections