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NCT Number: NCT07813988

Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

High-Volume Parasagittal Interlaminar Epidural Steroid Injection

Procedure

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

Low-Volume Parasagittal Interlaminar Epidural Steroid Injection

Procedure

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

Transforaminal Epidural Steroid Injection

Procedure

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Numerical Rating Scale Pain Score

    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

  2. Change in Oswestry Disability Index Score

    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.

  3. Total fluoroscopy time

    Time frame: During the index injection procedure

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

  4. number of fluoroscopic images

    Time frame: During the index injection procedure

    Total number of fluoroscopic images acquired during the index injection procedure. Measured by number of images.

  5. procedure duration

    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.

  6. Duration of Pain Relief

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

anas fetian, M.B.B.Ch., M.Sc.

CONTACT

[email protected]

+20 1275089656

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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