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

NCT ID: NCT05099796

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-05

Study Completion Date

2021-05-11

Brief Summary

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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

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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

Conditions

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Failed Back Surgery Syndrome Low Back Pain Radiculopathy Epidural Fibrosis

Keywords

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Failed back surgery syndrome, epidural steroid injections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transforaminal epidural steroid injection (TESI) group

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.

Group Type ACTIVE_COMPARATOR

Transforaminal epidural steroid injection

Intervention Type PROCEDURE

Caudal epidural steroid injection (CESI) group

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.

Group Type ACTIVE_COMPARATOR

Caudal epidural steroid injection

Intervention Type PROCEDURE

Interventions

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Transforaminal epidural steroid injection

Intervention Type PROCEDURE

Caudal epidural steroid injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Savas Sencan, Assoc. Prof.

Role: STUDY_DIRECTOR

Marmara University Pendik Training and Research Hospital

Locations

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Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2014.0085

Identifier Type: -

Identifier Source: org_study_id