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Taking people in United StatesPhase 4

Steroid pills added to pain medicine for osteoarthritis joint pain in emergency care

Tests prednisone or dexamethasone plus ibuprofen for osteoarthritis joint pain in emergency patients.

Key facts

Who runs it
WellSpan Health
Where
York, United StatesSee the site
Trial code
Registry title
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
Status
Recruiting
Phase
Phase 4
People taking part
192 people, planned
Started
24 Feb 2025
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Prednisone
  • Dexamethasone
  • Placebo
Record updated
19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who come to the emergency department with sudden pain in one knee, hip or shoulder from osteoarthritis. They must be going home from the emergency department.

Age
18 years and older
Sex
All sexes
Disease stage
Sudden pain in one joint (own knee, hip or shoulder), worse than usual, starting less than 72 hour before the visit. Osteoarthritis of that joint must be shown on X-ray now or on earlier imaging.
Earlier treatment
Cannot join with an injection into the painful joint within 60 days, a joint replacement of that joint, regular steroid use (more than 5 mg daily prednisone or equivalent in the last 7 days), or daily NSAID use for more than 2 days before the visit.

Main reasons for not taking part

  • Injury to the painful joint within 30 days
  • Heart artery disease, severe stomach or gut bleeding, stomach ulcers, kidney disease with GFR less than 30, or bleeding or platelet disorders
  • Joint pain thought to come from rheumatoid arthritis, gout, joint infection or other inflammatory arthritis
  • Daily prescription opioid use, opioid use disorder, or illegal drug use
  • Allergy or other reasons not to take ibuprofen/NSAIDs, prednisone or dexamethasone; pregnancy; planned hospital stay

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior arthroplasty of the affected joint
  • 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)
  • Illicit drug use
  • Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
  • Daily prescription opioid use or active opioid use disorder
  • Known allergy/intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms
  • Other conditions that would preclude compliance with the study protocol and medication dosing
  • 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)
  • Trauma to the affected joint within 30 days
  • Injection of affected joint within 60 days
  • Other contraindications to ibuprofen/NSAIDs or glucocorticoids
  • Planned hospitalization from the ED
  • Pregnancy
  • Incarceration
  • Inability to provide informed consent

Where in United States

  • Wellspan York HospitalYork, United StatesContact: Kristen OliffTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Intervention A - PrednisoneExisting treatment, for comparison

    Subjects assigned to the Intervention A group will receive prednisone 50 mg once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.

    Treatment: Prednisone

  • Intervention B - DexamethasoneExisting treatment, for comparison

    Subjects assigned to the Intervention B group will receive a single dose of dexamethasone 10 mg, plus ibuprofen 600 mg every 8 hours for 5 days.

    Treatment: Dexamethasone

  • Control - PlaceboPlacebo, for comparison

    Subjects assigned to the Control group will receive placebo once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
Plain-language title
Steroid pills added to pain medicine for osteoarthritis joint pain in emergency careGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
19 August 2026