ClinicalTrials.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

In context

Radiculopathy

483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

    Drug page: Triamcinolone

    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

    Drug page: Triamcinolone

    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

    Drug page: Triamcinolone

    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

06

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)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2026
First posted
Mar 27, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07494136
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Triamcinolone · Dexamethasone

Start the discussion