Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections

Active, not recruiting

• Conditions: Lumbar Disc Herniation; Radiculopathy Lumbar
• Interventions: Procedure: Transforaminal Epidural Steroid Injection; Procedure: Erector Spina Plane Block

• Registration Number: NCT05719792
• Lead Sponsor: Marmara University

Brief Summary

Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.

Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.

However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.

In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-01-16
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Being between the ages of 18-65
• Radicular low back pain
• Failure to respond to conservative treatments
• Single level lumbar nerve root compression due to disc herniation
• Agree to participate in the research

Exclusion Criteria

• Patients younger than 18 years and older than 65 years
• Those with non-radicular low back pain
• Those with nerve root compression due to reasons other than disc herniation
• Those with Modic type-1 changes in lumbar MRI
• Those with spinal stenosis or spondylolisthesis
• Those diagnosed with spondylodiscitis
• Pregnant
• Those with inflammatory rheumatic disease
• Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Those who had lumbar radicular pain	Transforaminal Epidural Steroid Injection	Patients with lumbar radicular pain identified by inclusion and exclusion criteria
Those who had lumbar radicular pain	Erector Spina Plane Block	Patients with lumbar radicular pain identified by inclusion and exclusion criteria

Primary Outcome Measures

Name	Time	Method
Change in NRS (Numeric Rating Scale)	at first hour, at three weeks, at 3 months, at 6 months	≥50% reduction in the NRS scores at month 6 relative to the initial NRS scores.
Change in ODI (Oswestry Disability Index)	at first hour, at three weeks, at 3 months, at 6 months	≥40% reduction in ODI scores at month 6 relative to the initial ODI scores.; (ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey