NCT06603662 Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department
| NCT ID | NCT06603662 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | WellSpan Health |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 192 participants in total. It began in 2025-02-24 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Brent Becker, MD
PRINCIPAL INVESTIGATOR
WellSpan Health
Frequently Asked Questions
Who can join the NCT06603662 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06603662 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06603662 currently recruiting?
Yes, NCT06603662 is actively recruiting participants. Contact the research team at koliff@wellspan.org for enrollment information.
Where is the NCT06603662 trial being conducted?
This trial is being conducted at York, United States.
Who is sponsoring the NCT06603662 clinical trial?
NCT06603662 is sponsored by WellSpan Health. The principal investigator is Brent Becker, MD at WellSpan Health. The trial plans to enroll 192 participants.