Dose Dependent Steroid Injections

March 20, 2026 updated by: Seyed Mostoufi, University of Miami

Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Nasacort® AQ, Kenalog
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
A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Nasacort® AQ, Kenalog
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
A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Nasacort® AQ, Kenalog
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
A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Decadron
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
A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Decadron
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
A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Numeric Rating Scale 0-10) (NRS)
Time Frame: 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.
Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function Oswestry Disability Index (ODI)
Time Frame: 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.
Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Quality of Life Short Form 36 (SF-36)
Time Frame: 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.
Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Seyed A mostoufi, MD, Christine E. Lynn Rehabilitation Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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