Dose Dependent Steroid Injections

Phase 4Not Yet RecruitingNCT07494136

University of Miami150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Lumbar Radiculopathy Sciatica Back Pain With Radiation

Interventions

Triamcinolone 10 Mg/mL Injectable SuspensionDRUG

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

Triamcinolone 40 Mg/mL Injectable SuspensionDRUG

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

Triamcinolone 80 Mg/mL Injectable SuspensionDRUG

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

Dexamethasone 2 MGDRUG

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

Dexamethasone 4mgDRUG

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

Dexamethasone 8 MGDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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.