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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone: 10 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg |
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| Triamcinolone: 40 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg |
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| Triamcinolone: 80 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg |
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| Dexamethasone: 2 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg. |
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| Dexamethasone: 4 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone 10 Mg/mL Injectable Suspension | Drug | A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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)] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nareka Trewick, MD | Contact | 305-243-6605 | nareka.trewick@jhsmiami.org |
| Name | Affiliation | Role |
|---|---|---|
| Seyed A mostoufi, MD | Christine E. Lynn Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D012585 | Sciatica |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020426 | Sciatic Neuropathy |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dexamethasone: 8 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg. |
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| Triamcinolone 40 Mg/mL Injectable Suspension | Drug | A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| Triamcinolone 80 Mg/mL Injectable Suspension | Drug | A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| Dexamethasone 2 MG | Drug | A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| Dexamethasone 4mg | Drug | A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| Dexamethasone 8 MG | Drug | A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. |
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| 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. | Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks) |
| D020422 | Mononeuropathies |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011246 | Pregnadienetriols |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |