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Not yet recruiting NCT07494136

Dose Dependent Steroid Injections

Phase IV Interventional Lumbar Radiculopathy Sciatica Back Pain With Radiation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension, Triamcinolone 80 Mg/mL Injectable Suspension, Dexamethasone 2 MG.
Who it may be relevant to
Registry conditions: Lumbar Radiculopathy, Sciatica, Back Pain With Radiation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy

Overview

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.

Interventions

  • Drug Triamcinolone 10 Mg/mL Injectable Suspension
    A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
  • Drug Triamcinolone 40 Mg/mL Injectable Suspension
    A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
  • Drug Triamcinolone 80 Mg/mL Injectable Suspension
    A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
  • Drug Dexamethasone 2 MG
    A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
  • Drug Dexamethasone 4mg
    A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
  • Drug Dexamethasone 8 MG
    A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

Primary outcome measures

  • 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)]]
Secondary outcome measures (2)
  • Physical Function Oswestry Disability Index (ODI) [Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07494136 · 20250853

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗