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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: caudal epidural steroid injection

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion Criteria

• Age between 30 and 80 years
• Patients with chronic low back pain (lasting longer than 6 months)
• Diagnosis of lumbar spinal stenosis (LSS) confirmed by imaging modalities (CT/MRI) and clinical evaluation
• LSS Diagnostic Support Tool Assessment (LSS-DST) score greater than 7
• Patients who did not benefit from previous conservative treatments
• Presence of a signed written informed consent form indicating willingness to participate in the study

LSS-DST (Lumbar Spinal Stenosis - Diagnostic Support Tool) Scoring System

• Age 60-70 years: +1 point
• Age over 70 years: +2 points
• Absence of Diabetes Mellitus: +1 point
• Positive claudication: +3 points
• Symptoms aggravated by standing: +2 points
• Symptoms relieved by forward flexion: +3 points
• Symptoms induced by forward flexion: -1 point
• Symptoms induced by lumbar extension: +1 point
• Ankle-brachial index ≥ 0.9: +3 points
• Abnormal Achilles tendon reflex: +1 point
• Positive straight leg raise test: -2 points

Exclusion Criteria:

History of lumbar epidural steroid injection within the last 6 months or history of major trauma

• Known allergy to the study medications (lidocaine hydrochloride, dexamethasone 21-phosphate) or to contrast agents
• Presence of unstable chronic medical conditions (e.g., diabetes mellitus, hypertension, chronic obstructive pulmonary disease, heart failure)
• Advanced joint limitations preventing mobilization (e.g., hip or knee osteoarthritis)
• History of previous lumbar spine surgery
• Current anticoagulant therapy or history of coagulopathy
• History of malignancy
• History of polyneuropathy
• Presence of peripheral vascular disease
• Psychiatric disorders or cognitive impairment that would interfere with completion of questionnaires and assessment scales (including significant visual or hearing impairment)
• Presence of local or systemic infection at the intended injection site
• Pregnancy and/or breastfeeding
• Refusal or inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: erector spinae plane block; Participants randomized to this arm received an ultrasound-guided lumbar erector spinae plane block with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain.	Procedure: Erector Spinae Plane Block; Ultrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions.
Active Comparator: caudal epidural steroid injection; Participants randomized to this arm received a fluoroscopy-guided caudal epidural steroid injection with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain.	Procedure: caudal epidural steroid injection; Caudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for Leg Pain	Visual Analog Scale (VAS) for leg pain measured on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.	Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.

Collaborators and Investigators

• Sponsor: Hatice Çetintürk Şahin
• Investigators: Principal Investigator: hatice çetintürk şahin, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Publications and helpful links

General Publications

• Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.
• Azevedo AS, Silva VTG, Xavier AL, da Silva LFF, Hojaij FC, Ashmawi HA, Vieira JE, Fernandes HS. Comparison of different injection volumes on spread of lumbar erector spinae plane block: An anatomical study. J Clin Anesth. 2021 Sep;72:110268. doi: 10.1016/j.jclinane.2021.110268. Epub 2021 Apr 10. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: 2024/1009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No