A Phase 4 interventional study of High-Volume Parasagittal Interlaminar Epidural Steroid Injection and Low-Volume Parasagittal Interlaminar Epidural Steroid Injection in Lumbar Disc Herniation and Lumbosacral Radiculopathy, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Benha University · Phase 4, Interventional, and Treatment
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.
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.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's planned enrollment of 99 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg.
Procedure: High-Volume Parasagittal Interlaminar Epidural Steroid Injection · Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate · Drug: Bupivacaine
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.
Procedure: Low-Volume Parasagittal Interlaminar Epidural Steroid Injection · Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate · Drug: Bupivacaine
participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.
Procedure: Transforaminal epidural steroid injection · Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate · Drug: Bupivacaine
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.
Also known as: High-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.
Also known as: Low-Volume PIL
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.
Also known as: TFESI
Drug pages: Betamethasone dipropionate · 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.
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.
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.
Time frame: 3 months after injection
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From injection through 6 months after injection
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2027, 13 months later.
Of 14 phase 4 interventional studies under Intervertebral Disc Displacement, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 101. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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