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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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