Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
This 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.
The 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.
The 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.
The 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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dr. Kashif Hussain
- Telefonní číslo: +923334841745
- E-mail: Kashifhussain543@hotmail.com
Studijní záloha kontaktů
- Jméno: Prof Dr. Leena Aziz
- E-mail: leenayub@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- Ghurki Trust & Teaching Hospital
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Kontakt:
- Ghurki Trust & Teaching Hospital
- Telefonní číslo: +92-42-111-348-348
- E-mail: info@ghurkitrust.org.pk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 18-75 years.
- Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.
- Pain duration > 6 weeks despite conservative therapy.
Exclusion Criteria:
- Previous epidural steroid injection in the past 6 months.
- Significant neurological deficits requiring immediate surgery.
- Coagulopathy or current anticoagulant therapy.
- Allergy to corticosteroids or contrast agents.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Group A: Caudal Epidural Steroid Injection (CEI)
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. |
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. |
|
Aktivní komparátor: 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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain intensity measured by Visual Analogue Scale (VAS)
Časové okno: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention
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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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Oswestry Disability Index (ODI)
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
|
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
|
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Health-Related Quality of Life measured by SF-36
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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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. |
Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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Duration of Pain Relief
Časové okno: From 1 week through 12 months after intervention
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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
|
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Procedure-Related Complications
Časové okno: From intervention through 12 months after intervention
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Procedure-related complications will be recorded and compared between participants receiving caudal and transforaminal epidural steroid injections. |
From intervention through 12 months after intervention
|
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Change in Functional Outcome Over 12 Months
Časové okno: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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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. |
Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Dr. Kashif Hussain, Ghurki Trust & Teaching Hospital
Publikace a užitečné odkazy
Obecné publikace
- Ozturk EC, Sacaklidir R, Sencan S, Gunduz OH. Caudal epidural steroid injection versus transforaminal ESI for unilateral S1 radiculopathy: a prospective, randomized trial. Pain Med. 2023 Aug 1;24(8):957-962. doi: 10.1093/pm/pnad041.
- Song JH, Lee WY, Cho KR, Nam SH, Park KD, Park Y. Fluoroscopy-Guided Transforaminal versus Caudal Epidural Steroid Injection for Chronic Pain After Spinal Surgery: A Retrospective Mid-Term Comparative Study. J Pain Res. 2021 Jul 13;14:2129-2138. doi: 10.2147/JPR.S314044. eCollection 2021.
- Li T, Gonzalez C, Provost J, Hasoon J, Nguyen A. Understanding the Landscape of Lumbar Epidural Steroid Injections: A Review of Interlaminar, Transforaminal, and Caudal Approaches. Orthop Rev (Pavia). 2025 May 23;17:138210. doi: 10.52965/001c.138210. eCollection 2025.
- Lee E, Lee JW, Kang HS. Interlaminar versus transforaminal epidural steroid injections: a review of efficacy and safety. Skeletal Radiol. 2023 Oct;52(10):1825-1840. doi: 10.1007/s00256-022-04124-3. Epub 2022 Jul 20.
- Imani F, Mohammad-Esmaeel F, Morsalli SF, Ahani-Azari A, Alimian M, Nikoubakht N, Emami A. Comparison of Clinical Effects and Physical Examination of Transforaminal and Caudal Steroid Injection With Targeted Catheter in Lumbar Radiculopathy: A Single-Blind Randomized Clinical Trial. Brain Behav. 2024 Oct;14(10):e70067. doi: 10.1002/brb3.70067.
- Choi EJ, Park SJ, Yoo YM, Yoon JU, Shin SW, Byeon GJ. Comparison of the Oblique Interlaminar and Transforaminal Lumbar Epidural Steroid Injections for Treatment of Low Back and Lumbosacral Radicular Pain. J Pain Res. 2021 Feb 15;14:407-414. doi: 10.2147/JPR.S293166. eCollection 2021.
- Bensler S, Walde M, Fischer MA, Pfirrmann CW, Peterson CK, Sutter R. Comparison of treatment outcomes in lumbar disc herniation patients treated with epidural steroid injections: interlaminar versus transforaminal approach. Acta Radiol. 2020 Mar;61(3):361-369. doi: 10.1177/0284185119858681. Epub 2019 Jul 2. No abstract available.
- Ahmed M, Ahmad A, Arshad M, Naseer H, Zamarud A. Ultrasound-Guided Versus Conventional Fluoroscopy-Guided Epidural Injection for Radiculopathy. A Meta-Analysis of Randomized Controlled Trials. World Neurosurg. 2023 Dec;180:203-212.e4. doi: 10.1016/j.wneu.2023.09.088. Epub 2023 Sep 27.
Užitečné odkazy
- <p>Ultrasound-guided versus conventional fluoroscopy-guided epidural injection for radiculopathy. A meta-analysis of randomized controlled trials.</p>
- <p>To study the efficacy of transforaminal epidural steroid injection in relieving lumbosacral radiculopathy.</p>
- <p>Comparison of the oblique interlaminar and transforaminal lumbar epidural steroid injections for treatment of low back and lumbosacral radicular pain.</p>
- <p>Factors associated with improved outcomes after lumbar transforaminal epidural steroid injections for radicular pain: A systematic review.</p>
- <p>Comparative Evaluation of Caudal Epidural Method to Ultrasound-Guided S1 Transforamen Block in Patient's Lumbar Discectomy with Failed Back Syndrome Symptoms: A Double-Blind Clinical Trial.</p>
- <p>Comparison between a single Subpedicular transforaminal epidural steroid injection and lateral recess steroid injection in reducing paracentral disc herniation-related chronic neuropathic leg pain: a retrospective study.</p>
- <p>Parasagittal Versus Transforaminal Epidural Steroid Injection, a Study of Contrast Flow in the Epidural Space and Clinical Outcomes: An RCT.</p>
- <p>Interlaminar versus transforaminal epidural steroid injections: a review of efficacy and safety.</p>
- <p>Understanding the landscape of lumbar epidural steroid injections: a review of interlaminar, transforaminal, and caudal approaches.</p>
- <p>Efficacy of epidural infiltration in the management of pain and disability due to acute and subacute lumbosacral radiculopathy.</p>
- <p>Effect of supraneural transforaminal epidural steroid injection combined with caudal epidural steroid injection with catheter in chronic radicular pain management: Double blinded randomized controlled trial.</p>
- <p>Comparative efficacy and safety of fluoroscopy-guided caudal epidural steroid injection and transforaminal epidural steroid injection for unilateral L5-S1 paracentral discogenic radicular pain.</p>
- <p>Comparison of 1-year results of single transforaminal epidural steroid injection among patients with different spinal pathologies-related radicular pain.</p>
- <p>A Comparative Study of the Effectiveness of Lumbar Steroid Injection in Kambin's Triangle Versus Conventional Transforaminal Approach for the Treatment of Lumbar Radicular Pain: A Prospective Randomised Study.</p>
- <p>Fluoroscopy-guided transforaminal versus caudal epidural steroid injection for chronic pain after spinal surgery: a retrospective mid-term comparative study.</p>
- <p>Role of transforaminal epidural injections or selective nerve root blocks in the management of lumbar radicular syndrome-a narrative, evidence-based review.</p>
- <p>Modified transforaminal epidural steroid injection combined with pulsed radiofrequency: an effective treatment measure for lumbar radiculopathy.</p>
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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