Health TrialsbyHealthPanel

Dose Dependent Steroid Injections

ConditionsLumbar RadiculopathySciaticaBack Pain With Radiation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults able to consent

Lumbar radiculopathy with MRI-confirmed pathology

No history of back surgery

Use of interlaminar approach lumbar spine injections

Disqualifiers

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

History of back surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Triamcinolone 10 Mg/mL Injectable Suspension

    Drug

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

  • Triamcinolone 40 Mg/mL Injectable Suspension

    Drug

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

  • Triamcinolone 80 Mg/mL Injectable Suspension

    Drug

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

  • Dexamethasone 2 MG

    Drug

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

  • Dexamethasone 4mg

    Drug

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

  • Dexamethasone 8 MG

    Drug

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

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Triamcinolone: 10 mg GroupExperimental treatment 1 intervention
Group B: Triamcinolone: 40 mg GroupExperimental treatment 1 intervention
Group C: Triamcinolone: 80 mg GroupExperimental treatment 1 intervention
Group D: Dexamethasone: 2 mg GroupExperimental treatment 1 intervention
Group E: Dexamethasone: 4 mg GroupExperimental treatment 1 intervention
Group F: Dexamethasone: 8 mg GroupExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: