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.
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
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
Parallel
Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation
Procedure/SurgeryLumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
Fluoroscopy-guided lumbar interlaminar epidural steroid injection
Procedure/SurgeryLumbar 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.
Patient Satisfaction
Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
Radiation Exposure
Radiation exposure measured as air kerma (mGy) 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.
Pain Intensity
Pain intensity assessed using the Numeric Rating Scale (NRS).
Functional Status
Functional status assessed using the Oswestry Disability Index (ODI).
Technical Success
Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.
Number of Needle Insertions
Number of needle insertion attempts required to complete the procedure.
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This trial is not recruiting at the moment. You can still explore other options:
