[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656957":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":41,"studyPopulation":32,"armGroups":42,"interventions":54,"overallOfficials":64,"centralContacts":69,"locations":77,"responsibleParty":94,"collaborators":32,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":32,"eligibilityCriteria":103,"healthyVolunteers":100,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":32,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":123,"whyStopped":32,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity measured by Visual Analogue Scale (VAS)","Pain intensity will be assessed using the Visual Analogue Scale (VAS) to compare pain relief between caudal epidural steroid injection and transforaminal epidural steroid injection groups.","Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Oswestry Disability Index (ODI)","Functional disability will be assessed using the Oswestry Disability Index (ODI) to compare functional outcomes between the caudal epidural steroid injection and transforaminal epidural steroid injection groups.","Baseline, 1 month, 3 months, 6 months, and 12 months after intervention",{"measure":19,"description":20,"timeFrame":17},"Health-Related Quality of Life measured by SF-36","Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire to compare quality-of-life outcomes between the two treatment groups.",{"measure":22,"description":23,"timeFrame":24},"Duration of Pain Relief","The duration and sustainability of pain relief following epidural steroid injection will be assessed and compared between the two treatment groups.","From 1 week through 12 months after intervention",{"measure":26,"description":27,"timeFrame":28},"Procedure-Related Complications","Procedure-related complications will be recorded and compared between participants receiving caudal and transforaminal epidural steroid injections.","From intervention through 12 months after intervention",{"measure":30,"description":31,"timeFrame":17},"Change in Functional Outcome Over 12 Months","Changes in functional status over the follow-up period will be assessed using the Oswestry Disability Index (ODI) and compared between the two treatment groups.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":39},"SINGLE",[40],"PARTICIPANT","Unilateral S1 nerve root pain is a common manifestation of lumbosacral radiculopathy and may persist despite conservative treatment. Epidural steroid injections are used as an interventional treatment option for patients with persistent radicular pain. Different approaches to epidural steroid delivery may produce different patterns of pain relief and functional improvement, but their comparative clinical effectiveness in patients with unilateral S1 nerve root pain remains an important clinical question.\n\nThis randomized controlled trial was designed to compare two approaches to epidural steroid administration: caudal epidural steroid injection and transforaminal epidural steroid injection. The study focuses on patients with unilateral S1 nerve root pain associated with imaging-confirmed nerve root compression who have persistent symptoms despite conservative management.\n\nThe principal purpose of the study is to characterize and compare the clinical response associated with the two injection approaches over an extended follow-up period. The study evaluates changes in pain and functional status together with patient-reported quality of life and satisfaction with treatment. The study also considers the duration and sustainability of treatment effects and documents treatment-related complications and adverse events.\n\nThe comparison is intended to provide clinical information regarding the relative effectiveness and safety of the two epidural injection approaches in the management of unilateral S1 nerve root pain. Assessment across multiple follow-up points allows the study to examine both the early response following treatment and the persistence of clinical effects over time.\n\nThe study uses a parallel-group randomized controlled design in which eligible participants are allocated to receive either caudal or transforaminal epidural steroid injection. The study procedures, eligibility criteria, outcome measures, follow-up schedule, and statistical methods are described in their respective sections of the clinical trial record.",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Group A: Caudal Epidural Steroid Injection (CEI)","ACTIVE_COMPARATOR","Participants receive a caudal epidural steroid injection through the sacral hiatus under fluoroscopic guidance. A corticosteroid combined with a local anesthetic is administered into the epidural space, with contrast dye used to confirm proper needle placement and epidural distribution.",[48],"Procedure: Caudal Epidural Steroid Injection (CEI)",{"label":50,"type":45,"description":51,"interventionNames":52},"Group B: Transforaminal Epidural Steroid Injection (TFI)","Participants receive a transforaminal epidural steroid injection targeting the affected S1 neural foramen under fluoroscopic guidance. A corticosteroid and local anesthetic mixture is administered, with contrast dye used to confirm proper epidural distribution.",[53],"Procedure: Transforaminal Epidural Steroid Injection (TFI)",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":32},"PROCEDURE","Caudal Epidural Steroid Injection (CEI)","A caudal epidural steroid injection is administered through the sacral hiatus into the epidural space under fluoroscopic guidance. Corticosteroid combined with a local anesthetic is administered, and contrast dye is used to confirm proper needle placement.",[44],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":32},"Transforaminal Epidural Steroid Injection (TFI)","A transforaminal epidural steroid injection is administered into the affected S1 neural foramen under fluoroscopic guidance. A steroid and local anesthetic mixture is administered, with contrast dye used to confirm proper epidural distribution.",[50],[65],{"name":66,"affiliation":67,"role":68},"Dr. Kashif Hussain","Ghurki Trust & Teaching Hospital","STUDY_CHAIR",[70,74],{"name":66,"role":71,"phone":72,"phoneExt":32,"email":73},"CONTACT","+923334841745","Kashifhussain543@hotmail.com",{"name":75,"role":71,"phone":32,"phoneExt":32,"email":76},"Prof Dr. Leena Aziz","leenayub@gmail.com",[78],{"facility":67,"status":32,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Lahore","Punjab Province","54000","Pakistan","PK",{"type":85,"coordinates":86},"Point",[87,88],74.35071,31.558,{"lat":88,"lon":87},[91],{"name":67,"role":71,"phone":92,"phoneExt":32,"email":93},"+92-42-111-348-348","info@ghurkitrust.org.pk",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Ahmad","PGR","100656957","comparison-of-efficacy-of-caudal-versus-transforaminal-epidural-steroid-injections-in-unilateral-s1-nerve-root-pain-a-randomized-controlled-trial-100656957",false,"NCT07833553","Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-75 years.\n* Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.\n* Pain duration \\> 6 weeks despite conservative therapy.\n\nExclusion Criteria:\n\n* Previous epidural steroid injection in the past 6 months.\n* Significant neurological deficits requiring immediate surgery.\n* Coagulopathy or current anticoagulant therapy.\n* Allergy to corticosteroids or contrast agents.","ALL","18 Years","75 Years",{"count":108,"type":109},120,"ESTIMATED","INTERVENTIONAL",[112],"NA","This study compares caudal and transforaminal epidural steroid injections for treating unilateral S1 nerve root pain. It evaluates pain relief, functional improvement, treatment satisfaction, quality of life, and complications over 12 months.",[115],"Unilateral S1 Nerve Root Pain",[117,118,119,120,121,122],"Radiculopathy","Epidural Steroid Injections","Lumbar radicular pain","S1 Radiculopathy","Oswestry Disability Index","Glucocorticoids","NOT_YET_RECRUITING","2026-09-16",{"date":126,"type":127},"2026-09-22","ACTUAL",{"date":129,"type":109},"2027-01-05",{"date":131,"type":109},"2028-02-05",{"name":5,"class":6},1]