Dose Dependent Steroid Injections

NCT07494136 — Phase 4, Not yet recruiting, 150 participants, University of Miami

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Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy

Registry	NCT07494136
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	150 (Estimated)
Sponsor	University of Miami (Other)
Conditions	Lumbar Radiculopathy, Sciatica, Back Pain With Radiation
Interventions	Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension, Triamcinolone 80 Mg/mL Injectable Suspension, Dexamethasone 2 MG, Dexamethasone 4mg, Dexamethasone 8 MG (Drug)
Dates	start 2026-09-15 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-03-27, last updated 2026-08-12
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Triamcinolone: 10 mg Group	Experimental	Drug: Triamcinolone 10 Mg/mL Injectable Suspension	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg
Triamcinolone: 40 mg Group	Experimental	Drug: Triamcinolone 40 Mg/mL Injectable Suspension	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg
Triamcinolone: 80 mg Group	Experimental	Drug: Triamcinolone 80 Mg/mL Injectable Suspension	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg
Dexamethasone: 2 mg Group	Experimental	Drug: Dexamethasone 2 MG	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.
Dexamethasone: 4 mg Group	Experimental	Drug: Dexamethasone 4mg	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.
Dexamethasone: 8 mg Group	Experimental	Drug: Dexamethasone 8 MG	Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.

Triamcinolone 10 Mg/mL Injectable Suspension (Drug), also known as Nasacort® AQ, Kenalog: A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Triamcinolone 40 Mg/mL Injectable Suspension (Drug), also known as Nasacort® AQ, Kenalog: A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Triamcinolone 80 Mg/mL Injectable Suspension (Drug), also known as Nasacort® AQ, Kenalog: A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 2 MG (Drug), also known as Decadron: A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 4mg (Drug), also known as Decadron: A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 8 MG (Drug), also known as Decadron: A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

+Outcome measures

Primary outcomes

Pain Intensity (Numeric Rating Scale 0-10) (NRS) [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

Physical Function Oswestry Disability Index (ODI) [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.
Quality of Life Short Form 36 (SF-36) [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of Miami	Miami, Florida	United States

+Investigators

Seyed A mostoufi, MD, Principal investigator, Christine E. Lynn Rehabilitation Center