Dose Dependent Steroid Injections

NCT07494136 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 20250853
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Radiculopathy; Sciatica; Back Pain With Radiation

Outcome Measures

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.

  Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]

Secondary Outcomes (2)

• Physical Function Oswestry Disability Index (ODI)

  Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)

• Quality of Life Short Form 36 (SF-36)

  Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)

Study Arms (6)

Triamcinolone: 10 mg Group

EXPERIMENTAL

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

Drug: Triamcinolone 10 Mg/mL Injectable Suspension

Triamcinolone: 40 mg Group

EXPERIMENTAL

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

Drug: Triamcinolone 40 Mg/mL Injectable Suspension

Triamcinolone: 80 mg Group

EXPERIMENTAL

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

Drug: Triamcinolone 80 Mg/mL Injectable Suspension

Dexamethasone: 2 mg Group

EXPERIMENTAL

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

Drug: Dexamethasone 2 MG

Dexamethasone: 4 mg Group

EXPERIMENTAL

Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg.

Drug: Dexamethasone 4mg

Dexamethasone: 8 mg Group

EXPERIMENTAL

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

Drug: Dexamethasone 8 MG

Interventions

Triamcinolone 10 Mg/mL Injectable Suspension DRUG

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

Also known as: Nasacort® AQ, Kenalog

Triamcinolone: 10 mg Group

Triamcinolone 40 Mg/mL Injectable Suspension DRUG

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

Also known as: Nasacort® AQ, Kenalog

Triamcinolone: 40 mg Group

Triamcinolone 80 Mg/mL Injectable Suspension DRUG

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

Also known as: Nasacort® AQ, Kenalog

Triamcinolone: 80 mg Group

Dexamethasone 2 MG DRUG

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

Also known as: Decadron

Dexamethasone: 2 mg Group

Dexamethasone 4mg DRUG

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

Also known as: Decadron

Dexamethasone: 4 mg Group

Dexamethasone 8 MG DRUG

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

Also known as: Decadron

Dexamethasone: 8 mg Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Radiculopathy; Sciatica; Back Pain

Interventions

Triamcinolone; Triamcinolone Acetonide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Seyed A mostoufi, MD

  Christine E. Lynn Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nareka Trewick, MD

CONTACT

305-243-6605; nareka.trewick@jhsmiami.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Processor, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)