Status:
RECRUITING
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
Lead Sponsor:
WellSpan Health
Conditions:
Osteoarthritis
Osteoarthritis (OA) of the Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to t...
Detailed Description
BACKGROUND Osteoarthritis (OA) constitutes a significant disease burden both within the United States (US) and globally. Recent data shows that upwards of 527 million people worldwide were affected b...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
- Acute pain above baseline starting less than 72 hour prior to ED visit
- Planned discharge from the ED
- History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging
Exclusion
- Trauma to the affected joint within 30 days
- Injection of affected joint within 60 days
- Prior arthroplasty of the affected joint
- History of coronary artery disease, severe gastrointestinal bleeding, gastric/peptic ulcer disease, chronic kidney disease with GFR less than 30, or platelet disorders (including von Willebrand disease, hemophilia, severe thrombocytopenia with platelets less than 50 k/mcL)
- Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
- Chronic/baseline use of glucocorticoids (greater than 5 mg daily prednisone or equivalent within previous 7 days) or NSAIDs (daily use for more than 2 days prior to presentation)
- Daily prescription opioid use or active opioid use disorder
- Illicit drug use
- Known allergy/intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms
- Other contraindications to ibuprofen/NSAIDs or glucocorticoids
- Planned hospitalization from the ED
- Pregnancy
- Incarceration
- Inability to provide informed consent
- Other conditions that would preclude compliance with the study protocol and medication dosing
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06603662
Start Date
February 24 2025
End Date
December 1 2027
Last Update
March 27 2025
Active Locations (1)
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1
WellSpan York Hospital
York, Pennsylvania, United States, 17403