Actively Recruiting
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
Led by WellSpan Health · Updated on 2025-03-27
192
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions. In brief, the central aims of the study are to: 1. Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis. 2. Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain. We hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated. Participants in the study will be randomized (like flipping a coin) into one of three groups: 1. Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 2. Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 3. Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days. In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen. Participants will: * Receive follow up phone calls at 1, 3, 7 and 14 days. * Report pain scores related to joint pain. * Report the number of pills taken of the various medications used in the study. * Report any adverse events incurred during the follow up period.
CONDITIONS
Official Title
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed related to osteoarthritis
- Acute pain above baseline starting less than 72 hours prior to emergency department visit
- Planned discharge from the emergency department
- History of osteoarthritis of the affected joint confirmed by radiography or prior imaging
You will not qualify if you...
- Trauma to the affected joint within 30 days
- Injection of affected joint within 60 days
- Prior joint replacement (arthroplasty) of the affected joint
- History of coronary artery disease, severe gastrointestinal bleeding, gastric or peptic ulcer disease, chronic kidney disease with GFR less than 30, or platelet disorders
- Joint pain suspected to be caused by rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
- Chronic or baseline use of glucocorticoids (more than 5 mg prednisone or equivalent daily 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 or intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other study medications
- Other contraindications to ibuprofen/NSAIDs or glucocorticoids
- Planned hospitalization from the emergency department
- Pregnancy
- Incarceration
- Inability to provide informed consent
- Other conditions that would prevent compliance with study protocol and medication dosing
AI-Screening
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Trial Site Locations
Total: 1 location
1
WellSpan York Hospital
York, Pennsylvania, United States, 17403
Actively Recruiting
Research Team
K
Kristen Oliff Oliff
CONTACT
B
Brent Becker, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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