Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis

Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis

Lumbar spinal stenosis is a common degenerative condition that can cause chronic low back and leg pain, especially during walking or standing. Interlaminar epidural steroid injections are widely used to relieve pain and improve function in patients who do not respond adequately to conservative treatments.

These injections are usually performed under fluoroscopic guidance, which allows accurate needle placement but exposes patients and healthcare providers to ionizing radiation. Ultrasound guidance has emerged as an alternative technique that avoids radiation exposure; however, ultrasound alone may not always confirm correct epidural spread of the injected medication.

This prospective, randomized clinical trial aims to compare two commonly used imaging approaches for interlaminar epidural steroid injections in patients with lumbar spinal stenosis: fluoroscopy-guided injection and ultrasound-guided injection with fluoroscopic confirmation (hybrid technique). The study will evaluate patient satisfaction, radiation exposure, procedure time, technical success, pain relief, and functional outcomes.

The results of this study are expected to help identify the most effective and safe imaging guidance method for interlaminar epidural steroid injections in patients with lumbar spinal stenosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation; Procedure: Fluoroscopy-guided lumbar interlaminar epidural steroid injection

Detailed Description

This prospective, randomized clinical trial will compare two imaging guidance strategies for interlaminar epidural steroid injection in adult patients diagnosed with lumbar spinal stenosis. Eligible participants will be randomly allocated into two groups: a fluoroscopy-guided interlaminar epidural steroid injection group and an ultrasound-guided interlaminar epidural steroid injection group with fluoroscopic confirmation of epidural spread (hybrid technique).

All procedures will be performed at a single tertiary care center by experienced clinicians using standardized institutional protocols. In both groups, the interlaminar epidural space will be accessed using a midline or paramedian approach, and the same corticosteroid formulation and injection volume will be administered to ensure treatment consistency.

Procedural outcomes will include total procedure time, fluoroscopy time, radiation dose parameters recorded directly from the fluoroscopy unit, and technical success defined as correct epidural space access with appropriate contrast spread. Radiation exposure will be assessed using dose metrics provided by the imaging system, allowing comparison between the two guidance techniques.

Patient-reported outcomes will be evaluated using validated pain and functional assessment tools at baseline and during routine follow-up visits according to the study protocol. Patient satisfaction will be assessed following the procedure. Adverse events related to the procedure will be documented and monitored throughout the study period.

By systematically comparing these two imaging guidance approaches under standardized clinical conditions, this study aims to clarify whether ultrasound-guided interlaminar epidural steroid injection with fluoroscopic confirmation can reduce radiation exposure while maintaining procedural efficiency, technical accuracy, and clinical effectiveness comparable to conventional fluoroscopy-guided injection.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Pendik
    • Istanbul, Pendik, Turkey (Türkiye), 34899
      • Marmara University Pendik Training and Research Hospital
      • Contact: Gamze G Güleç, MD; Phone Number: +905528671324; Email: gamzegulgulec@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 40 and 75 years
• Diagnosis of lumbar spinal stenosis confirmed by clinical evaluation and magnetic resonance imaging (MRI)
• Presence of neurogenic claudication symptoms for at least 3 months
• Inadequate response to conservative treatment, including medication, physical therapy, or exercise
• Numeric Rating Scale (NRS) pain score ≥ 4 at baseline
• Ability to provide written informed consent

Exclusion Criteria:

• Previous lumbar spine surgery
• Vertebral fracture, spinal malignancy, or history of significant lumbar trauma
• Peripheral vascular claudication or clinically significant peripheral polyneuropathy
• Epidural steroid injection within the past 6 months
• Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip/knee osteoarthritis)
• Pregnancy or breastfeeding
• Coagulation disorders or inability to safely discontinue anticoagulant or antiplatelet therapy according to guideline recommendations
• Known allergy to local anesthetics, corticosteroids, or contrast agents
• Active local or systemic infection
• Body mass index (BMI) > 30 kg/m²

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection; Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.	Procedure: Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation; Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
Active Comparator: Fluoroscopy-guided lumbar interlaminar epidural steroid injection; Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.	Procedure: Fluoroscopy-guided lumbar interlaminar epidural steroid injection; Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed according to standard clinical practice under fluoroscopic guidance, with fluoroscopic confirmation of needle position and contrast spread.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction with the procedure was assessed using a 5-point Likert scale.	Immediately after the procedure
Radiation Exposure	Radiation exposure measured as air kerma (mGy) during the procedure.	During the procedure
Procedure Time	Procedure time defined as the duration from identification of the target interlaminar space using ultrasound or fluoroscopy to completion of the injection.	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Pain intensity assessed using the Numeric Rating Scale (NRS).	Baseline, 1 hour, and 3 weeks after the procedure
Functional Status	Functional status assessed using the Oswestry Disability Index (ODI).	Baseline and 3 weeks after the procedure
Technical Success	Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.	During the procedure
Number of Needle Insertions	Number of needle insertion attempts required to complete the procedure.	During the procedure
Fluoroscopy Time	Total fluoroscopy time automatically recorded by the fluoroscopy unit during the procedure.	During the procedure

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Radiation exposure; Fluoroscopy; Interventional Ultrasonography; Epidural Injections
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Spinal Stenosis; Patient Satisfaction
• Other Study ID Numbers: MU-HYBRID-ILESI-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly. De-identified aggregate data may be available upon reasonable request, subject to institutional policies and ethical approval.

Drug and device information, study documents

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