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

NCT06603662 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-03-27

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • WellSpan Health

    lead OTHER

Principal Investigators

  • Brent Becker, MD · WellSpan Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603662 on ClinicalTrials.gov