Lumbar Spinal StenosisNCT07612982
Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis
A study testing Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation and Fluoroscopy-guided lumbar interlaminar epidural steroid injection in people with Lumbar Spinal Stenosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation and Fluoroscopy-guided lumbar interlaminar epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Numeric Rating Scale (NRS) pain score ≥ 4 at baseline
- Ability to provide written informed consent
Who cannot join
- 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
- Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip/knee osteoarthritis)
- Pregnancy or breastfeeding
Show all 10Show fewer
- Coagulation disorders or inability to safely discontinue anticoagulant or antiplatelet therapy according to guideline recommendations
- Known allergy to local anesthetics, corticosteroids, or contrast agents
- Active local or systemic infection
- Body mass index (BMI) > 30 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Gamze G Güleç, MD, +905528671324, gamzegulgulec@gmail.com
About this study
Official title: Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation, Fluoroscopy-guided lumbar interlaminar epidural steroid injection
- Keywords
- Fluoroscopy, Radiation exposure, Patient satisfaction, Interventional Ultrasonography, Epidural Injections
- Medical subject headings
- Spinal Stenosis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmationProcedure or surgery
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 injectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection | Experimental | Lumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread. Receives: Procedure: Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation |
| Fluoroscopy-guided lumbar interlaminar epidural steroid injection | Active comparator | 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. Receives: Procedure: Fluoroscopy-guided lumbar interlaminar epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
Measured: Immediately after the procedure
Radiation Exposure
Radiation exposure measured as air kerma (mGy) during the procedure.
Measured: 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.
Measured: During the procedure
Secondary outcomes (5)
Pain Intensity
Pain intensity assessed using the Numeric Rating Scale (NRS).
Measured: Baseline, 1 hour, and 3 weeks after the procedure
Functional Status
Functional status assessed using the Oswestry Disability Index (ODI).
Measured: Baseline and 3 weeks after the procedure
Technical Success
Successful completion of interlaminar epidural steroid injection with confirmed epidural spread.
Measured: During the procedure
Number of Needle Insertions
Number of needle insertion attempts required to complete the procedure.
Measured: During the procedure
Fluoroscopy Time
Total fluoroscopy time automatically recorded by the fluoroscopy unit during the procedure.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJul 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612982
- Sponsor's protocol ID
- MU-HYBRID-ILESI-2026
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07612982
- Acronym / sponsor ID
- MU-HYBRID-ILESI-2026
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Fluoroscopy, Radiation exposure, Patient satisfaction, Interventional Ultrasonography, Epidural Injections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection | Experimental | Procedure: Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmationLumbar 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 | Active comparator | Procedure: Fluoroscopy-guided lumbar interlaminar epidural steroid injectionLumbar 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Numeric Rating Scale (NRS) pain score ≥ 4 at baseline
Key exclusion criteria (10 listed)
- 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
- Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip/knee osteoarthritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmationLumbar interlaminar epidural steroid injection using betamethasone (CALES) will be performed under ultrasound guidance, followed by fluoroscopic confirmation of needle position and contrast spread. | Procedure or surgery | Ultrasound-assisted fluoroscopy-confirmed lumbar interlaminar epidural steroid injection |
| Fluoroscopy-guided lumbar interlaminar epidural steroid injectionLumbar 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 or surgery | Fluoroscopy-guided lumbar interlaminar epidural steroid injection |
Primary outcome
Patient Satisfaction
Time frame: Immediately after the procedure
Patient satisfaction with the procedure was assessed using a 5-point Likert scale.
Radiation Exposure
Time frame: During the procedure
Radiation exposure measured as air kerma (mGy) during the procedure.
Procedure Time
Time frame: 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.
5 secondary outcomes
Pain Intensity
Time frame: Baseline, 1 hour, and 3 weeks after the procedure
Functional Status
Time frame: Baseline and 3 weeks after the procedure
Technical Success
Time frame: During the procedure
Number of Needle Insertions
Time frame: During the procedure
Fluoroscopy Time
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation and Fluoroscopy-guided lumbar interlaminar epidural steroid injection in people with Lumbar Spinal Stenosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: Immediately after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.