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Trials / Completed

CompletedNCT07445477

Erector Spinae Plane vs Caudal Epidural Steroid in Lumbar Spinal Stenosis Resistant to Conservative Therapy

A Prospective Comparative Study Evaluating the Effectiveness of Erector Spinae Plane Block Versus Caudal Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis Refractory to Conservative Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hatice Çetintürk Şahin · Academic / Other
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Lumbar spinal stenosis is a common cause of neurogenic claudication and functional limitation in older adults. Epidural steroid injections are frequently used in patients who do not respond to conservative treatments. The erector spinae plane block has recently emerged as a potential alternative interventional technique for pain control in lumbar spine disorders. This prospective comparative study will evaluate and compare the effectiveness of erector spinae plane block and caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment. Clinical outcomes including pain intensity, functional status, and walking capacity will be assessed at predefined follow-up intervals. The study aims to determine whether erector spinae plane block provides comparable or superior clinical benefit compared with caudal epidural steroid injection in this patient population.

Detailed description

This prospective, randomized, parallel-group comparative study was conducted to evaluate the clinical effectiveness of ultrasound-guided lumbar erector spinae plane block compared with fluoroscopy-guided caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment. Eligible participants were randomized into two intervention arms. Patients in the erector spinae plane block group received a lumbar 4 level ultrasound-guided injection of local anesthetic administered under sterile conditions. Patients in the caudal epidural steroid injection group received a fluoroscopy-guided caudal epidural injection consisting of corticosteroid and local anesthetic according to institutional protocol. The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS) for leg pain. Assessments were performed before the procedure, 1 hour after injection, and at 4 and 8 weeks following the intervention. Secondary clinical evaluations included functional status and walking capacity assessed at predefined follow-up intervals. The study was approved by the local ethics committee, and written informed consent was obtained from all participants prior to enrollment.

Conditions

Interventions

TypeNameDescription
PROCEDUREErector Spinae Plane BlockUltrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions.
PROCEDUREcaudal epidural steroid injectionCaudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol.

Timeline

Start date
2024-10-10
Primary completion
2026-01-10
Completion
2026-02-10
First posted
2026-03-03
Last updated
2026-03-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07445477. Inclusion in this directory is not an endorsement.