What this study is
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.
What's being tested
- Triamcinolone 10 Mg/mL Injectable Suspension
Intervention · DRUG
A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
- Triamcinolone 40 Mg/mL Injectable Suspension
Intervention · DRUG
A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
- Triamcinolone 80 Mg/mL Injectable Suspension
Intervention · DRUG
A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
- Dexamethasone 2 MG
Intervention · DRUG
A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
- Dexamethasone 4mg
Intervention · DRUG
A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
- Dexamethasone 8 MG
Intervention · DRUG
A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Study details
- Official title
- Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy
- Sponsor
- University of Miami
- Conditions
- Lumbar Radiculopathy · Sciatica · Back Pain With Radiation
- Enrolling
- 150 people
- Starts
- 2026-09-15
- Est. completion
- 2027-05
- Design
- Single-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Miami
Miami, Florida, United States
- Nareka Trewick, MD · Contact305-243-6605nareka.trewick@jhsmiami.org
Study team
Sponsor
University of Miami
Study ID 20250853
Principal investigator
Seyed A mostoufi, MD
Christine E. Lynn Rehabilitation Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.