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In this pilot study, the investigators aim to compare two short-term pain relief methods administered over the course of 6 days in the setting of acute musculoskeletal (MSK) pain:
The investigators are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Active Comparator | Arm 1 dosing scheme: Day 1: 2 tabs (8mg) before breakfast, 1 tab (4mg) at lunch and dinner, 2 tabs (8mg) at bedtime (6 tabs total) Day 2: 1 tab (4mg) before breakfast, lunch and dinner and 2 tabs (8mg) at bedtime (5 tabs total) Day 3: 1 tab (4mg) before breakfast, lunch and dinner and 1 tab (4mg) at bedtime (4 tabs total) Day 4: 1 tab (4mg) before breakfast, lunch and dinner (3 tabs total) Day 5: 1 tab (4mg) before breakfast and at bedtime (2 tabs total) Day 6: 1 tab (4mg) before breakfast (1 tab total) |
|
| Oral Acetaminophen and Ibuprofen | Active Comparator | Arm 2 dosing scheme: Day 1: day of consent: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol Extra- Strength (ES)(1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 2: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 3: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 4: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner Day 5: 3 tabs ibuprofen (600mg) at breakfast and 2 tabs Tylenol ES (1000mg) at bedtime Day 6: 3 tabs ibuprofen (600mg) at breakfast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone 4Mg Tab | Drug | Participants follow standard 6- day taper dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Pain as self-reported by the patient, following pain medication treatment for an acute musculoskeletal (MSK) injury as measured with the Visual Analog Scale (VAS) where 0 is no pain at all and 10 is the worst pain imaginable. Lower scores indicate less pain. | 1 week, 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Function | Function as self-reported by the patient following pain medication treatment for an acute musculoskeletal (MSK) injury as measured with the musculoskeletal health questionnaire (MSK-HQ) scale which sums 14 health domains on a 5-point scale from 4 being not at all and 0 to very severe. Higher scores indicate better overall MSK health. | 1 week, 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBMD Orthopaedics and Sports Medicine (716 Health) | Buffalo | New York | 14221 | United States |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Acetaminophen 500Mg Tab | Drug | Participants follow a 6- day taper dosing schedule. |
|
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| Ibuprofen 200Mg Oral Tablet | Drug | Participants follow a 6- day taper dosing schedule. |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |