CClinicalTrials.gg
Not yet recruitingNCT07494136Updated Aug 12, 2026

Dose Dependent Steroid Injections

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

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lumbar Radiculopathy
  • Sciatica
  • Back Pain With Radiation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Triamcinolone: 10 mg Group

    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg

    Drug: Triamcinolone 10 Mg/mL Injectable Suspension

  • Experimental
    Triamcinolone: 40 mg Group

    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg

    Drug: Triamcinolone 40 Mg/mL Injectable Suspension

  • Experimental
    Triamcinolone: 80 mg Group

    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg

    Drug: Triamcinolone 80 Mg/mL Injectable Suspension

  • Experimental
    Dexamethasone: 2 mg Group

    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg.

    Drug: 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.

    Drug: Dexamethasone 4mg

  • Experimental
    Dexamethasone: 8 mg Group

    Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg.

    Drug: Dexamethasone 8 MG

Interventions

  • DrugTriamcinolone 10 Mg/mL Injectable Suspension

    A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Nasacort® AQ, Kenalog

  • DrugTriamcinolone 40 Mg/mL Injectable Suspension

    A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Nasacort® AQ, Kenalog

  • DrugTriamcinolone 80 Mg/mL Injectable Suspension

    A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Nasacort® AQ, Kenalog

  • DrugDexamethasone 2 MG

    A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Decadron

  • DrugDexamethasone 4mg

    A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Decadron

  • DrugDexamethasone 8 MG

    A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.

    Also known as: Decadron

05

What researchers measure

Primary outcomes

  1. 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)]

Secondary outcomes

  1. 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)

  2. 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)

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07494136
Lead sponsor
University of Miami
Responsible party
Seyed Mostoufi (Associate Processor, Physical Medicine and Rehabilitation, University of Miami) — Principal investigator
First posted
Mar 27, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Nareka Trewick, MD
Contact
nareka.trewick@jhsmiami.org
305-243-6605
Seyed A mostoufi, MD
principal investigator · Christine E. Lynn Rehabilitation Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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