Health TrialsbyHealthPanel

Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain

ConditionsLumbar Disc HerniationLumbosacral Radiculopathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-Volume Parasagittal Interlaminar Epidural Steroid Injection

    Procedure/Surgery

    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 Injection

    Procedure/Surgery

    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 injection

    Procedure/Surgery

    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 Phosphate

    Drug

    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

    Drug

    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.

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: High-Volume PILExperimental treatment 3 interventions
Group B: Low-Volume PILExperimental treatment 3 interventions
Group C: TFESIExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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
3

Total fluoroscopy time

Total duration of fluoroscopy exposure during the index injection procedure. Measured in seconds.

Time frame
During the index injection procedure
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: