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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorMarmara University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation
  • Fluoroscopy-guided lumbar interlaminar epidural steroid injection

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators