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

NCT07445477 | Completed

• 1 other identifier: 2024/1009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

erector spinae plane block

ACTIVE COMPARATOR

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

caudal epidural steroid injection

ACTIVE COMPARATOR

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

Interventions

Erector Spinae Plane Block PROCEDURE

Ultrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions.

erector spinae plane block

caudal epidural steroid injection PROCEDURE

Caudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol.

caudal epidural steroid injection

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hatice Çetintürk Şahin: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23615883 BACKGROUND

• 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.

  PMID: 33848824 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• hatice çetintürk şahin

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 3, 2026
• Study Start: October 10, 2024
• Primary Completion: January 10, 2026
• Study Completion: February 10, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)