Lumbar Radiculopathy, Sciatica, Back Pain With Radiation
Conditions
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.
Interventions
DRUGTriamcinolone 10 Mg/mL Injectable Suspension
A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
DRUGTriamcinolone 40 Mg/mL Injectable Suspension
A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
DRUGTriamcinolone 80 Mg/mL Injectable Suspension
A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
DRUGDexamethasone 4mg
A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Numeric Rating Scale 0-10) (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function Oswestry Disability Index (ODI) | 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. |
| Quality of Life Short Form 36 (SF-36) | 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. |
Countries
United States
Contacts
CONTACTNareka Trewick, MD
PRINCIPAL_INVESTIGATORSeyed A mostoufi, MD
Christine E. Lynn Rehabilitation Center
Outcome results
None listed