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

NCT07612982 | Not Yet Recruiting

• 1 other identifier: MU-HYBRID-ILESI-2026
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Fluoroscopy; Radiation exposure; Patient satisfaction; Interventional Ultrasonography; Epidural Injections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Pain Intensity

  Baseline, 1 hour, and 3 weeks after the procedure

• Functional Status

  Baseline and 3 weeks after the procedure

• Technical Success

  During the procedure

• Number of Needle Insertions

  During the procedure

• Fluoroscopy Time

  During the procedure

Study Arms (2)

Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection

EXPERIMENTAL

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

Fluoroscopy-guided lumbar interlaminar epidural steroid injection

ACTIVE COMPARATOR

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

Interventions

Fluoroscopy-guided lumbar interlaminar epidural steroid injection PROCEDURE

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.

Fluoroscopy-guided lumbar interlaminar epidural steroid injection

Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation PROCEDURE

Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.

Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Stenosis; Patient Satisfaction

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)