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This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen + dexamethasone + educational intervention | Experimental | Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. |
|
| Ibuprofen + placebo + educational intervention | Placebo Comparator | Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg | Drug | Ibuprofen 400 mg PO every 8 hours as needed for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Roland Morris Disability Questionnaire (RMDQ) score | The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2) | 2 days (48 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Radicular LBP | Worst Radicular LBP pain incurred over the previous 24 hours will be assessed at 2 days and 7 days after ED discharge using a four point ordinal scale: Severe, Moderate, Mild, or None | 2 days and 7 days after ED discharge |
| Frequency of Radicular LBP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eddie Irizarry, MD | Contact | 718-920-6626 | eddiriza@montefiore.org |
| Name | Affiliation | Role |
|---|---|---|
| Eddie Irizarry, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED | Recruiting | The Bronx | New York | 10461 | United States |
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| Label | URL |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information | View source |
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No plan to share
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D003907 | Dexamethasone |
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dexamethasone Oral | Drug | Dexamethasone 16 mg PO during ED visit and next day |
|
| Educational Intervention | Behavioral | Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information |
|
Frequency of Radicular LBP is evaluated at 2 days and 7 days after ED discharge based on a five point Likert scale: Not at all, Rarely, Sometimes, Usually, and Always |
| 2 days and 7 days after ED discharge |
| Analgesic or LBP medication within the previous 24 hours | Administration of any analgesic or LBP medication (Yes or No) within the previous 24 hours will be assessed at 2 days and 7 days after ED discharge | 2 days and 7 days after ED discharge |
| Absolute Roland Morris Disability Questionnaire (RMDQ) score | The Absolute RMDQ score will be tabulated at 2 days and 7 days after ED discharge. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability | 2 days and 7 days after ED discharge |
| Return to all usual activities | The patient will be evaluated for the ability to return to all usual activities at 2 days and 7 days after ED discharge based on a binary (Yes/No) response | 2 days and 7 days after ED discharge |
| Number of visits to any healthcare provider | The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge | 2 days and 7 days after ED discharge |
| Satisfaction with Treatment | Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge | 2 days and 7 days after ED discharge |
| Montefiore Medical Center - Moses ED | Recruiting | The Bronx | New York | 10467 | United States |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011246 |
| Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |