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NCT Number: NCT07494136

Dose Dependent Steroid Injections

This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.

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Key information

Conditions

Lumbar Radiculopathy Back Pain Back Pain With Radiation Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults able to consent
  • Lumbar radiculopathy with MRI-confirmed pathology
  • No history of back surgery
  • Use of interlaminar approach lumbar spine injections
  • No use of oral pain medication other than Tylenol or Acetaminophen during the 6 weeks after injection

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • History of back surgery
  • Use of oral pain meds other than Tylenol or Acetaminophen during the 6 weeks after injection

Treatment and study plan

Triamcinolone 10 Mg/mL Injectable Suspension

Drug

A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Nasacort® AQ, Kenalog

Triamcinolone 40 Mg/mL Injectable Suspension

Drug

A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Nasacort® AQ, Kenalog

Triamcinolone 80 Mg/mL Injectable Suspension

Drug

A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Nasacort® AQ, Kenalog

Dexamethasone 2 MG

Drug

A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Decadron

Dexamethasone 4mg

Drug

A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Decadron

Dexamethasone 8 mg

Drug

A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Other names: Decadron

Primary outcomes

  1. Pain Intensity (Numeric Rating Scale 0-10) (NRS)

    Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]

    Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 verbal rating scale in which participants rate their pain on a continuum from 0 (pain) to 10 (max pain). Higher scores indicate greater pain severity.

Secondary outcomes

  1. Physical Function Oswestry Disability Index (ODI)

    Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)

    Physical function will be measured using the Oswestry Disability Index (ODI), a validated Physical Function Scale from 0% to 100%. The ODI consists of multiple sections, each scored from 0 to 5, with higher scores indicating greater functional impairment. The total score is summed and divided by 50 when all sections are completed, or by 45 if the optional section is excluded. Final scores are expressed as a percentage ranging from 0% (minimal disability) to 100% (bed-bound), with higher percentages representing more severe disability.

  2. Quality of Life Short Form 36 (SF-36)

    Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)

    Quality of life will be measured using Quality of Life Measure with domain scores from 0 to 100 with, higher scores indicating better health or fewer limitations in that domain.

Study contacts

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

Nareka Trewick, MD

CONTACT

[email protected]

305-243-6605

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 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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