Benha University Hospital
Banhā, Qalyubia Governorate, Egypt
NCT Number: NCT07813988
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 4
Banhā, Qalyubia Governorate, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: 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.
Other names: TFESI
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.
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.
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after injection.
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 from baseline in Oswestry Disability Index score; scores are expressed from 0% to 100%, with higher scores indicating greater disability.
Time frame: During the index injection procedure
Total duration of fluoroscopy exposure during the index injection procedure. Measured in seconds.
Time frame: During the index injection procedure
Total number of fluoroscopic images acquired during the index injection procedure. Measured by number of images.
Time frame: During the index injection procedure
Total duration of the index injection procedure, measured from the start of the procedure until completion of the injection. Measured in minutes.
Time frame: From injection through 6 months after injection
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.
Contact information is provided by the study sponsor or research team.
Benha University
Other
Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections
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