Study of Steroids for Acute Osteoarthritis Pain in the Emergency Department

This study is looking at whether adding steroid medications to standard pain relief helps adults who come to the emergency department with sudden, severe joint pain from osteoarthritis (OA). Osteoarthritis is a common condition where the protective cartilage on the ends of your bones wears down over time. Participants will receive either prednisone (a steroid) for 5 days, a single dose of dexamethasone (another steroid), or a placebo (an inactive substance), all in addition to ibuprofen for 5 days. Researchers want to see if the steroids reduce pain more effectively after 3 days and if they are safe to use. You might be able to join if you are 18 or older and have acute OA pain in your knee, hip, or shoulder that started recently.

Study design
This interventional study plans to enroll 192 participants. It compares three groups: two receiving different steroid medications plus ibuprofen, and one receiving a placebo plus ibuprofen.
What's involved
Participants will receive oral medication for 5 days. The study will measure pain at 3 days and check for any side effects for 28 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety outcomes for 28 days after starting treatment.

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NCT06603662

Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department

Recruiting
PHASE4Ages 18+InterventionalTreatment
WellSpan Health
~192 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PrednisoneDexamethasonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Resting Pain Score at 3 Days (Effectiveness Outcome)
Measured over 3 days (72 hours)
+1 more outcome measured
Osteoarthritis
Osteoarthritis (OA) of the Knee
Osteoarthritis (OA) of the Shoulder
Osteoarthritis (OA) of the Hip
1 sites across 1 states
Pennsylvania1
  • Brent Becker, MD · PRINCIPAL_INVESTIGATOR · WellSpan Health

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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
  • Change in Resting Pain Score at 3 Days (Effectiveness Outcome)3 days (72 hours)

    Change in resting pain score from baseline at time of randomization based on subject-reported numerical resting pain score (0-10) for pain in the affected joint obtained during the follow up phone call on Day 3.

  • Adverse Events (Safety Outcome)28 days

    Occurrence of adverse events reported during follow up phone calls on Day 1, 3, 7 and 14 or during chart review on Day 14 and 28, including: * Hyperglycemia requiring discontinuation of the study medication * Diabetic ketoacidosis or hospitalization for diabetes-related process * Bleeding events, including gastrointestinal bleeding (GIB) * Abdominal pain requiring discontinuation of the study medication * Worsening renal function requiring discontinuation of the study medication * Other adverse events necessitating discontinuation of study medication * Repeat visit to an emergency department * Hospitalization * Death