[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640258":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":28,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Marmara University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Procedure: Fluoroscopy-guided lumbar interlaminar epidural steroid injection",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Ultrasound-guided lumbar interlaminar epidural steroid injection with fluoroscopic confirmation",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"facility":30,"status":25,"city":31,"state":32,"zip":33,"country":34,"countryCode":25,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Marmara University Pendik Training and Research Hospital","Istanbul","Pendik","34899","Turkey (Türkiye)",{"type":36,"coordinates":37},"Point",[38,39],28.94966,41.01384,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":25,"email":46},"Gamze G Güleç, MD","CONTACT","+905528671324","gamzegulgulec@gmail.com",{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100640258","hybrid-vs-fluoroscopy-guided-interlaminar-epidural-injection-in-lumbar-spinal-stenosis-100640258",false,"NCT07612982","Hybrid vs Fluoroscopy-Guided Interlaminar Epidural Injection in Lumbar Spinal Stenosis","Comparison of Hybrid and Fluoroscopy-Guided Interlaminar Epidural Steroid Injections on Patient Satisfaction, Radiation Dose and Procedure Time in Lumbar Spinal Stenosis","Inclusion Criteria:\n\n* Age between 40 and 75 years\n* Diagnosis of lumbar spinal stenosis confirmed by clinical evaluation and magnetic resonance imaging (MRI)\n* Presence of neurogenic claudication symptoms for at least 3 months\n* Inadequate response to conservative treatment, including medication, physical therapy, or exercise\n* Numeric Rating Scale (NRS) pain score ≥ 4 at baseline\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Previous lumbar spine surgery\n* Vertebral fracture, spinal malignancy, or history of significant lumbar trauma\n* Peripheral vascular claudication or clinically significant peripheral polyneuropathy\n* Epidural steroid injection within the past 6 months\n* Medical conditions severely limiting ambulation unrelated to lumbar spinal stenosis (e.g., severe cardiopulmonary disease or advanced hip\u002Fknee osteoarthritis)\n* Pregnancy or breastfeeding\n* Coagulation disorders or inability to safely discontinue anticoagulant or antiplatelet therapy according to guideline recommendations\n* Known allergy to local anesthetics, corticosteroids, or contrast agents\n* Active local or systemic infection\n* Body mass index (BMI) \\> 30 kg\u002Fm²","ALL","40 Years","75 Years",{"count":60,"type":61},44,"ESTIMATED","INTERVENTIONAL",[64],"NA","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.\n\nThese 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.\n\nThis 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.\n\nThe 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.",[67],"Lumbar Spinal Stenosis",[69,70,71,72,73],"Fluoroscopy","Radiation exposure","Patient satisfaction","Interventional Ultrasonography","Epidural Injections","NOT_YET_RECRUITING","2026-05-28",{"date":77,"type":78},"2026-05-29","ACTUAL",{"date":80,"type":61},"2026-07",{"date":82,"type":61},"2027-01",{"name":5,"class":6},1]