Unilateral S1 Nerve Root PainNCT07833553
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
A study testing Caudal Epidural Steroid Injection (CEI) and Transforaminal Epidural Steroid Injection (TFI) in people with Unilateral S1 Nerve Root Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unilateral S1 Nerve Root Pain
- What is being tested?
- Caudal Epidural Steroid Injection (CEI) and Transforaminal Epidural Steroid Injection (TFI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2027to 5 Feb 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.
- Pain duration > 6 weeks despite conservative therapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof Dr. Leena Aziz contact
Pakistan1 site
Ghurki Trust & Teaching Hospital
Lahore, Punjab Province, 54000
Ghurki Trust & Teaching Hospital, +92-42-111-348-348, info@ghurkitrust.org.pk
About this study
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.
Read the detailed description
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.
- Conditions
- Unilateral S1 Nerve Root Pain
- Being tested
- Caudal Epidural Steroid Injection (CEI), Transforaminal Epidural Steroid Injection (TFI)
- Keywords
- Radiculopathy, Epidural Steroid Injections, Lumbar radicular pain, S1 Radiculopathy, Oswestry Disability Index, Glucocorticoids
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Epidural Steroid Injection (CEI)Procedure or surgery
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.
Transforaminal Epidural Steroid Injection (TFI)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Caudal Epidural Steroid Injection (CEI) |
| Group B: Transforaminal Epidural Steroid Injection (TFI) | Active comparator | 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. Receives: Procedure: Transforaminal Epidural Steroid Injection (TFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention
Secondary outcomes (5)
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.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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.
Measured: From 1 week through 12 months after intervention
Procedure-Related Complications
Procedure-related complications will be recorded and compared between participants receiving caudal and transforaminal epidural steroid injections.
Measured: From intervention through 12 months after intervention
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.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start5 Jan 2027 (estimated)
- Primary completion2 Feb 2028 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Unilateral S1 Nerve Root PainStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad, University of Health Sciences Lahore
- Investigators
- Dr. Kashif Hussain, Study chair, Ghurki Trust & Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833553
- Sponsor's protocol ID
- 01-07-2025
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34285573Li 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.
PubMed 40416592Lee 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.
PubMed 35859019Imani 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.
PubMed 39363795Ozturk 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.
PubMed 37004169Choi 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.
PubMed 33623423Bensler 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.
PubMed 31265320Ahmed 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.
PubMed 37774791
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07833553
- Acronym / sponsor ID
- 01-07-2025
- Conditions
- Unilateral S1 Nerve Root Pain
- Keywords
- Radiculopathy, Epidural Steroid Injections, Lumbar radicular pain, S1 Radiculopathy, Oswestry Disability Index, Glucocorticoids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 5 Jan 2027 (estimated)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 22 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Caudal Epidural Steroid Injection (CEI) | Active comparator | Procedure: 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. |
| Group B: Transforaminal Epidural Steroid Injection (TFI) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years.
- Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.
- Pain duration > 6 weeks despite conservative therapy.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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. | Procedure or surgery | Group A: Caudal Epidural Steroid Injection (CEI) |
| 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. | Procedure or surgery | Group B: Transforaminal Epidural Steroid Injection (TFI) |
Primary outcome
Pain intensity measured by Visual Analogue Scale (VAS)
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention
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.
5 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Health-Related Quality of Life measured by SF-36
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Duration of Pain Relief
Time frame: From 1 week through 12 months after intervention
Procedure-Related Complications
Time frame: From intervention through 12 months after intervention
Change in Functional Outcome Over 12 Months
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
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 16 Oct 2026.
- Background: PubMed 34285573Song 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.
- Background: PubMed 40416592Li 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.
- Background: PubMed 35859019Lee 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.
- Background: PubMed 39363795Imani 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.
- Background: PubMed 37004169Ozturk 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.
- Background: PubMed 33623423Choi 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.
- Background: PubMed 31265320Bensler 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.
- Background: PubMed 37774791Ahmed 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.
- Ultrasound-guided versus conventional fluoroscopy-guided epidural injection for radiculopathy. A meta-analysis of randomized controlled trials.Link provided by the sponsor.
- To study the efficacy of transforaminal epidural steroid injection in relieving lumbosacral radiculopathy.Link provided by the sponsor.
- Comparison of the oblique interlaminar and transforaminal lumbar epidural steroid injections for treatment of low back and lumbosacral radicular pain.Link provided by the sponsor.
- Factors associated with improved outcomes after lumbar transforaminal epidural steroid injections for radicular pain: A systematic review.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Prof Dr. Leena Aziz contact
Dr. Kashif Hussain study chair
Ghurki Trust & Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Epidural Steroid Injection (CEI) and Transforaminal Epidural Steroid Injection (TFI) in people with Unilateral S1 Nerve Root Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 3 inclusion and 4 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 16 Oct 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 Pakistan. 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?
Contact Dr. Kashif Hussain (+923334841745, Kashifhussain543@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by Visual Analogue Scale (VAS) (time frame: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07833553, which also lists 8 linked publications.
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 16 Oct 2026.