Dose Dependent Steroid Injections

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07494136
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Back Pain With Radiation
  • Lumbar Radiculopathy
  • Sciatica

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Triamcinolone: 10 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg
  • Experimental: Triamcinolone: 40 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg
  • Experimental: Triamcinolone: 80 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg
  • Experimental: Dexamethasone: 2 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.
  • Experimental: Dexamethasone: 4 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.
  • Experimental: Dexamethasone: 8 mg Group
    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.

Primary Outcome Measure

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)] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Nareka Trewick, MD
[email protected]
305-243-6605

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University of Miami· Miami, FL

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