[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655417":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":47,"studyPopulation":36,"armGroups":48,"interventions":67,"overallOfficials":36,"centralContacts":93,"locations":99,"responsibleParty":116,"collaborators":36,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":36,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":36,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":149,"whyStopped":36,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Benha University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of Participants With Clinically Meaningful Pain Response","Responder status is defined as a reduction from baseline of at least 2 points or at least 30% in Numerical Rating Scale (NRS) pain score. The association between contrast-spread variables and responder status will be assessed.","3 months after injection",[14,18,22,26,29,32],{"measure":15,"description":16,"timeFrame":17},"Change in Numerical Rating Scale Pain Score","Mean change from baseline in pain intensity measured using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity. Change in NRS pain score will be calculated as the score at each follow-up time point minus the baseline score.\n\nUnits of measure: i'd use points on a scale","Baseline, 2 weeks, 1 month, 3 months, and 6 months after injection.",{"measure":19,"description":20,"timeFrame":21},"Change in Oswestry Disability Index Score","Change from baseline in Oswestry Disability Index score; scores are expressed from 0% to 100%, with higher scores indicating greater disability.","Baseline; 2 weeks, 1 month, 3 months, and 6 months after injection",{"measure":23,"description":24,"timeFrame":25},"Total fluoroscopy time","Total duration of fluoroscopy exposure during the index injection procedure. Measured in seconds.","During the index injection procedure",{"measure":27,"description":28,"timeFrame":25},"number of fluoroscopic images","Total number of fluoroscopic images acquired during the index injection procedure. Measured by number of images.",{"measure":30,"description":31,"timeFrame":25},"procedure duration","Total duration of the index injection procedure, measured from the start of the procedure until completion of the injection. Measured in minutes.",{"measure":33,"description":34,"timeFrame":35},"Duration of Pain Relief","Time from index injection to loss of benefit, defined as return to less than 30% NRS reduction from baseline or participant request for repeat intervention or surgical referral.","From injection through 6 months after injection",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":43,"whoMasked":44},"DOUBLE","Participants will be blinded to the assigned injection approach and injectate volume. Outcome assessors collecting pain and disability scores and radiographic assessors evaluating contrast-spread images will be blinded to treatment allocation. The procedural physician cannot be blinded because of inherent differences between injection techniques. Statistical analysis will be conducted with the analyst blinded to arm assignment where feasible.",[45,46],"PARTICIPANT","OUTCOMES_ASSESSOR","Lumbar disc herniation may cause lumbosacral radicular pain through nerve-root compression and inflammation. Fluoroscopy-guided epidural steroid injections are commonly used when symptoms persist despite conservative treatment. Parasagittal interlaminar (PIL) and transforaminal epidural steroid injection (TFESI) approaches may produce different patterns of contrast distribution within the epidural space. It remains unclear whether contrast spread pattern independently predicts clinical response, apart from injection approach and injectate volume.\n\nThis prospective, three-arm randomized clinical trial will enroll adults with unilateral lumbosacral radicular pain and magnetic resonance imaging-confirmed lumbar disc herniation. Participants will be allocated in a 1:1:1 ratio to high-volume PIL injection (10 mL), low-volume PIL injection (7 mL), or TFESI (3 mL). Before administration of the therapeutic injectate, 2 mL of non-ionic iodinated contrast medium will be injected under real-time fluoroscopy to confirm epidural placement, exclude intravascular or intrathecal injection, and document contrast distribution.\n\nBlinded assessors will classify contrast spread according to ventral epidural spread, laterality, foraminal or nerve-root spread, epidural distribution pattern, and cephalocaudal extent. Dynamic fluoroscopic assessment will measure time to first ventral opacification. Participants, radiographic assessors, and outcome assessors will be blinded to treatment allocation where feasible; the procedural physician cannot be blinded because of the procedural differences.\n\nThe study will assess whether contrast spread variables independently predict responder status at 3 months, defined as a reduction of at least 2 points or 30% from baseline in Numerical Rating Scale pain score. Additional outcomes include changes in pain intensity and Oswestry Disability Index scores, procedural efficiency, duration of pain relief, and responder status during follow-up through 6 months.",[49,57,62],{"label":50,"type":51,"description":52,"interventionNames":53},"High-Volume PIL","EXPERIMENTAL","Participants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg.",[54,55,56],"Procedure: High-Volume Parasagittal Interlaminar Epidural Steroid Injection","Drug: Betamethasone Dipropionate \u002F Betamethasone Sodium Phosphate","Drug: Bupivacaine",{"label":58,"type":51,"description":59,"interventionNames":60},"Low-Volume PIL","PILParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 7 mL therapeutic injectate: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.",[61,55,56],"Procedure: Low-Volume Parasagittal Interlaminar Epidural Steroid Injection",{"label":63,"type":51,"description":64,"interventionNames":65},"TFESI","participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.",[66,55,56],"Procedure: Transforaminal epidural steroid injection",[68,74,79,84,89],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"PROCEDURE","High-Volume Parasagittal Interlaminar Epidural Steroid Injection","Fluoroscopy-guided parasagittal interlaminar epidural steroid injection on the symptomatic side. After a standardized 2 mL non-ionic iodinated contrast injection, 10 mL therapeutic injectate is administered: betamethasone 24 mg and bupivacaine 0.5% 20 mg.",[50],[50],{"type":69,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Low-Volume Parasagittal Interlaminar Epidural Steroid Injection","Fluoroscopy-guided parasagittal interlaminar epidural steroid injection on the symptomatic side. After a standardized 2 mL non-ionic iodinated contrast injection, 7 mL therapeutic injectate is administered: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.",[58],[58],{"type":69,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Transforaminal epidural steroid injection","Fluoroscopy-guided transforaminal epidural steroid injection at the symptomatic level and side. After a standardized 2 mL non-ionic iodinated contrast injection, 3 mL therapeutic injectate is administered: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.",[63],[63],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":36},"DRUG","Betamethasone Dipropionate \u002F Betamethasone Sodium Phosphate","Administered in volume-proportional doses: 24 mg in High-Volume PIL, 16.8 mg in Low-Volume PIL, and 7.2 mg in TFESI.",[50,58,63],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":36},"Bupivacaine","Bupivacaine 0.5% is administered in volume-proportional doses: 20 mg in High-Volume PIL, 14 mg in Low-Volume PIL, and 6 mg in TFESI.",[50,58,63],[94],{"name":95,"role":96,"phone":97,"phoneExt":36,"email":98},"anas fetian, M.B.B.Ch., M.Sc.","CONTACT","+20 1275089656","a.ftyan48177@fmed.bu.edu.eg",[100],{"facility":101,"status":36,"city":102,"state":103,"zip":36,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":112},"Benha University Hospital","Banhā","Qalyubia Governorate","Egypt","EG",{"type":107,"coordinates":108},"Point",[109,110],31.1842,30.45977,{"lat":110,"lon":109},[113],{"name":114,"role":96,"phone":115,"phoneExt":36,"email":98},"Anas Fetian, MD","+201275089656",{"type":117,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Samar Rafik Mohamed Amin","assistant professor of anesthesia and intensive care","100655417","phase-4-comparing-three-epidural-steroid-injection-approaches-for-lumbar-radicular-pain-100655417",false,"NCT07813988","Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain","Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Unilateral lumbosacral radicular pain consistent with a dermatomal distribution.\n* Magnetic resonance imaging-confirmed lumbar disc herniation (bulge, protrusion, or extrusion) at the corresponding clinical level.\n* Persistent symptoms despite at least 6 weeks of conservative management, including analgesics and physiotherapy.\n* Baseline Numerical Rating Scale pain score of 4 or greater.\n* American Society of Anesthesiologists physical status I to III.\n* Ability to understand and complete outcome assessments.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Previous lumbar spine surgery or failed back surgery syndrome.\n* Red-flag signs, including foot drop, urinary incontinence, or cauda equina syndrome.\n* Bilateral radicular symptoms or central canal stenosis requiring surgical intervention.\n* Coagulopathy or ongoing anticoagulant therapy.\n* Local or systemic infection or hepatic dysfunction.\n* Known allergy to contrast medium, local anesthetics, or corticosteroids.\n* Pregnancy.\n* Severe renal impairment contraindicating contrast use.\n* Chronic opioid use, defined as daily opioid use for more than 3 months before enrollment.\n* Uncontrolled systemic disease, including unstable diabetes or severe cardiopulmonary disease.\n* Inability to comply with follow-up.","ALL","18 Years","65 Years",{"count":131,"type":132},99,"ESTIMATED","INTERVENTIONAL",[135],"PHASE4","This study will compare three fluoroscopy-guided epidural steroid injection approaches for adults with unilateral lumbosacral radicular pain caused by lumbar disc herniation. The study will evaluate whether the pattern of contrast spread in the epidural space predicts meaningful pain relief.\n\nNinety-nine participants will be randomly assigned in equal numbers to receive one of three treatments: high-volume parasagittal interlaminar injection, low-volume parasagittal interlaminar injection, or transforaminal epidural steroid injection. Participants will not be told which injection approach they receive. Pain and disability will be assessed before treatment and at 2 weeks, 1 month, 3 months, and 6 months after injection. The main outcome is the proportion of participants with clinically meaningful improvement in pain at 3 months.",[138,139],"Lumbar Disc Herniation","Lumbosacral Radiculopathy",[141,142,143,144,145,146,147,148],"Epidural Steroid Injection","Parasagittal Interlaminar Injection","Transforaminal Epidural Steroid Injection","Radicular Pain","Fluoroscopy","Oswestry Disability Index","Numerical Rating Scale","Contrast Spread","NOT_YET_RECRUITING","2026-09-10",{"date":152,"type":153},"2026-09-14","ACTUAL",{"date":155,"type":132},"2026-10",{"date":157,"type":132},"2028-02",{"name":5,"class":6},1]