Lumbar Disc HerniationPhase 4NCT07813988
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain
A Phase 4 study testing High-Volume Parasagittal Interlaminar Epidural Steroid Injection, Low-Volume Parasagittal Interlaminar Epidural Steroid Injection and Transforaminal epidural steroid injection in people with Lumbar Disc Herniation and Lumbosacral Radiculopathy, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbosacral Radiculopathy
- What is being tested?
- High-Volume Parasagittal Interlaminar Epidural Steroid Injection, Low-Volume Parasagittal Interlaminar Epidural Steroid Injection and Transforaminal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Feb 2028
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Unilateral lumbosacral radicular pain consistent with a dermatomal distribution.
- Magnetic resonance imaging-confirmed lumbar disc herniation (bulge, protrusion, or extrusion) at the corresponding clinical level.
- Persistent symptoms despite at least 6 weeks of conservative management, including analgesics and physiotherapy.
- Baseline Numerical Rating Scale pain score of 4 or greater.
- American Society of Anesthesiologists physical status I to III.
- Ability to understand and complete outcome assessments.
- Written informed consent provided.
Who cannot join
- Previous lumbar spine surgery or failed back surgery syndrome.
- Red-flag signs, including foot drop, urinary incontinence, or cauda equina syndrome.
- Bilateral radicular symptoms or central canal stenosis requiring surgical intervention.
- Coagulopathy or ongoing anticoagulant therapy.
- Local or systemic infection or hepatic dysfunction.
- Known allergy to contrast medium, local anesthetics, or corticosteroids.
Show all 11Show fewer
- Pregnancy.
- Severe renal impairment contraindicating contrast use.
- Chronic opioid use, defined as daily opioid use for more than 3 months before enrollment.
- Uncontrolled systemic disease, including unstable diabetes or severe cardiopulmonary disease.
- Inability to comply with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā, Qalyubia Governorate
Anas Fetian, MD, +201275089656, a.ftyan48177@fmed.bu.edu.eg
About this study
Official title: Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections
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.
Ninety-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.
Read the detailed description
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.
This 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.
Blinded 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.
The 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.
- Conditions
- Lumbar Disc Herniation, Lumbosacral Radiculopathy
- Being tested
- High-Volume Parasagittal Interlaminar Epidural Steroid Injection, Low-Volume Parasagittal Interlaminar Epidural Steroid Injection, Transforaminal epidural steroid injection, Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Bupivacaine
- Keywords
- Epidural Steroid Injection, Parasagittal Interlaminar Injection, Transforaminal Epidural Steroid Injection, Radicular Pain, Fluoroscopy, Oswestry Disability Index, Numerical Rating Scale, Contrast Spread
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Volume Parasagittal Interlaminar Epidural Steroid InjectionProcedure or surgery
Also called High-Volume PIL
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.
Low-Volume Parasagittal Interlaminar Epidural Steroid InjectionProcedure or surgery
Also called Low-Volume PIL
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.
Transforaminal epidural steroid injectionProcedure or surgery
Also called TFESI
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.
Betamethasone Dipropionate / Betamethasone Sodium PhosphateDrug
Administered in volume-proportional doses: 24 mg in High-Volume PIL, 16.8 mg in Low-Volume PIL, and 7.2 mg in TFESI.
BupivacaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: High-Volume Parasagittal Interlaminar Epidural Steroid Injection; Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate; Drug: Bupivacaine |
| Low-Volume PIL | Experimental | 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. Receives: Procedure: Low-Volume Parasagittal Interlaminar Epidural Steroid Injection; Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate; Drug: Bupivacaine |
| TFESI | Experimental | participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg. Receives: Procedure: Transforaminal epidural steroid injection; Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after injection
Secondary outcomes (6)
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.
Units of measure: i'd use points on a scale
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months after injection.
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.
Measured: Baseline; 2 weeks, 1 month, 3 months, and 6 months after injection
Total fluoroscopy time
Total duration of fluoroscopy exposure during the index injection procedure. Measured in seconds.
Measured: During the index injection procedure
number of fluoroscopic images
Total number of fluoroscopic images acquired during the index injection procedure. Measured by number of images.
Measured: During the index injection procedure
procedure duration
Total duration of the index injection procedure, measured from the start of the procedure until completion of the injection. Measured in minutes.
Measured: During the index injection procedure
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.
Measured: From injection through 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813988
- Sponsor's protocol ID
- MD.2.7.2026
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data-sharing plan has been established. This approach protects participant privacy and is consistent with institutional ethics and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections
- ClinicalTrials.gov ID
- NCT07813988
- Acronym / sponsor ID
- MD.2.7.2026
- Conditions
- Lumbar Disc Herniation, Lumbosacral Radiculopathy
- Keywords
- Epidural Steroid Injection, Parasagittal Interlaminar Injection, Transforaminal Epidural Steroid Injection, Radicular Pain, Fluoroscopy, Oswestry Disability Index, Numerical Rating Scale, Contrast Spread
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 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 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.
Ninety-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.
Detailed description
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.
This 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.
Blinded 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.
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Volume PIL | Experimental | Procedure: High-Volume Parasagittal Interlaminar Epidural Steroid Injection, Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Drug: BupivacaineParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg. |
| Low-Volume PIL | Experimental | Procedure: Low-Volume Parasagittal Interlaminar Epidural Steroid Injection, Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Drug: BupivacainePILParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 7 mL therapeutic injectate: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg. |
| TFESI | Experimental | Procedure: Transforaminal epidural steroid injection, Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Drug: Bupivacaineparticipants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 65 years.
- Unilateral lumbosacral radicular pain consistent with a dermatomal distribution.
- Magnetic resonance imaging-confirmed lumbar disc herniation (bulge, protrusion, or extrusion) at the corresponding clinical level.
- Persistent symptoms despite at least 6 weeks of conservative management, including analgesics and physiotherapy.
- Baseline Numerical Rating Scale pain score of 4 or greater.
Key exclusion criteria (11 listed)
- Previous lumbar spine surgery or failed back surgery syndrome.
- Red-flag signs, including foot drop, urinary incontinence, or cauda equina syndrome.
- Bilateral radicular symptoms or central canal stenosis requiring surgical intervention.
- Coagulopathy or ongoing anticoagulant therapy.
- Local or systemic infection or hepatic dysfunction.
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 |
|---|---|---|
| High-Volume Parasagittal Interlaminar Epidural Steroid InjectionAlso: High-Volume PILFluoroscopy-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. | Procedure or surgery | High-Volume PIL |
| Low-Volume Parasagittal Interlaminar Epidural Steroid InjectionAlso: Low-Volume PILFluoroscopy-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. | Procedure or surgery | Low-Volume PIL |
| Transforaminal epidural steroid injectionAlso: TFESIFluoroscopy-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. | Procedure or surgery | TFESI |
| Betamethasone Dipropionate / Betamethasone Sodium PhosphateAdministered in volume-proportional doses: 24 mg in High-Volume PIL, 16.8 mg in Low-Volume PIL, and 7.2 mg in TFESI. | Drug | High-Volume PIL, Low-Volume PIL, TFESI |
| BupivacaineBupivacaine 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. | Drug | High-Volume PIL, Low-Volume PIL, TFESI |
Primary outcome
Proportion of Participants With Clinically Meaningful Pain Response
Time frame: 3 months after injection
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.
6 secondary outcomes
Change in Numerical Rating Scale Pain Score
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after injection.
Change in Oswestry Disability Index Score
Time frame: Baseline; 2 weeks, 1 month, 3 months, and 6 months after injection
Total fluoroscopy time
Time frame: During the index injection procedure
number of fluoroscopic images
Time frame: During the index injection procedure
procedure duration
Time frame: During the index injection procedure
Duration of Pain Relief
Time frame: From injection through 6 months after injection
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data-sharing plan has been established. This approach protects participant privacy and is consistent with institutional ethics and data-protection requirements.
Related trials for Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
Lumber Disc Prolapse
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-Volume Parasagittal Interlaminar Epidural Steroid Injection, Low-Volume Parasagittal Interlaminar Epidural Steroid Injection and Transforaminal epidural steroid injection in people with Lumbar Disc Herniation and Lumbosacral Radiculopathy, run by Benha University at 1 site in Egypt.
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 8 inclusion and 11 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 14 Sep 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 anas fetian, M.B.B.Ch., M.Sc. (+20 1275089656, a.ftyan48177@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Clinically Meaningful Pain Response (time frame: 3 months after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.