A Phase 4 interventional study of Triamcinolone 10 Mg/mL Injectable Suspension and Triamcinolone 40 Mg/mL Injectable Suspension in Lumbar Radiculopathy, Sciatica and Back Pain With Radiation, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg
Drug: Triamcinolone 10 Mg/mL Injectable Suspension
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg
Drug: Triamcinolone 40 Mg/mL Injectable Suspension
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg
Drug: Triamcinolone 80 Mg/mL Injectable Suspension
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.
Drug: Dexamethasone 2 MG
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.
Drug: Dexamethasone 4mg
Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.
Drug: Dexamethasone 8 MG
A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Nasacort® AQ, Kenalog
A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Nasacort® AQ, Kenalog
A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Nasacort® AQ, Kenalog
A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Decadron
A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Decadron
A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Also known as: Decadron
Pain Intensity (Numeric Rating Scale 0-10) (NRS)
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.
Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]
Physical Function Oswestry Disability Index (ODI)
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.
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)
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.
Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Miami