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

NCT07612982 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-11-30
Completion
2027-01-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612982 on ClinicalTrials.gov