An interventional study of Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation and Fluoroscopy-guided lumbar interlaminar epidural steroid injection in Lumbar Spinal Stenosis, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
This prospective, randomized clinical trial will compare two imaging guidance strategies for interlaminar epidural steroid injection in adult patients diagnosed with lumbar spinal stenosis. Eligible participants will be randomly allocated into two groups: a fluoroscopy-guided interlaminar epidural steroid injection group and an ultrasound-guided interlaminar epidural steroid injection group with fluoroscopic confirmation of epidural spread (hybrid technique).
All procedures will be performed at a single tertiary care center by experienced clinicians using standardized institutional protocols. In both groups, the interlaminar epidural space will be accessed using a midline or paramedian approach, and the same corticosteroid formulation and injection volume will be administered to ensure treatment consistency.
Procedural outcomes will include total procedure time, fluoroscopy time, radiation dose parameters recorded directly from the fluoroscopy unit, and technical success defined as correct epidural space access with appropriate contrast spread. Radiation exposure will be assessed using dose metrics provided by the imaging system, allowing comparison between the two guidance techniques.
Patient-reported outcomes will be evaluated using validated pain and functional assessment tools at baseline and during routine follow-up visits according to the study protocol. Patient satisfaction will be assessed following the procedure. Adverse events related to the procedure will be documented and monitored throughout the study period.
By systematically comparing these two imaging guidance approaches under standardized clinical conditions, this study aims to clarify whether ultrasound-guided interlaminar epidural steroid injection with fluoroscopic confirmation can reduce radiation exposure while maintaining procedural efficiency, technical accuracy, and clinical effectiveness comparable to conventional fluoroscopy-guided injection.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 44 is below the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread.
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.
Patient Satisfaction
Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
Time frame: Immediately after the procedure
Radiation Exposure
Radiation exposure measured as air kerma (mGy) during the procedure.
Time frame: 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.
Time frame: During the procedure
Pain Intensity
Pain intensity assessed using the Numeric Rating Scale (NRS).
Time frame: Baseline, 1 hour, and 3 weeks after the procedure
Functional Status
Functional status assessed using the Oswestry Disability Index (ODI).
Time frame: Baseline and 3 weeks after the procedure
Technical Success
Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.
Time frame: During the procedure
Number of Needle Insertions
Number of needle insertion attempts required to complete the procedure.
Time frame: During the procedure
Fluoroscopy Time
Total fluoroscopy time automatically recorded by the fluoroscopy unit during the procedure.
Time frame: During the procedure
Plan to share: No — Individual participant data will not be shared publicly. De-identified aggregate data may be available upon reasonable request, subject to institutional policies and ethical approval.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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