Recruiting

Glucocorticoids

Sponsor:

WellSpan Health

Code:

NCT06603662

Conditions

Osteoarthritis

Osteoarthritis (OA) of the Knee

Osteoarthritis (OA) of the Shoulder

Osteoarthritis (OA) of the Hip

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prednisone

Dexamethasone

Placebo

Study Details

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 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

Osteoarthritis

Osteoarthritis (OA) of the Knee

Osteoarthritis (OA) of the Shoulder

Osteoarthritis (OA) of the Hip

Study ID

NCT06603662

Start date

Feb 24, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention A - Prednisone

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.

active comparator: Intervention B - Dexamethasone

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.

placebo comparator: Control - Placebo

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.

Interventions

Prednisone

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

Dexamethasone

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

Placebo

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

Primary outcome measure

  • Change in Resting Pain Score at 3 Days (Effectiveness Outcome) [ Time Frame: 3 days (72 hours) ]
  • Adverse Events (Safety Outcome) [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Kristen Oliff Oliff

717-812-5075koliff@wellspan.org

Brent Becker, MD

717-851-4819bbecker2@wellspan.org

Locations

WellSpan York Hospital

Recruiting

York, Pennsylvania, United States, 17403

Contacts

Kristen Oliff

717-812-5075koliff@wellspan.org

Brent Becker, MD

717-851-4819bbecker2@wellspan.org

More Information

Sponsor

WellSpan Health

Last update posted

Aug 19, 2026

Last verified

Jun, 2026

Keywords

  • osteoarthritis
  • acute pain
  • glucocorticosteroids
  • emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by WellSpan Health on 2026-08-19.