RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-24
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06603662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years
  2. * Acute monoarticular arthritic joint pain affecting native knee, hip, or shoulder presumed to be related to osteoarthritis
  3. * Acute pain above baseline starting less than 72 hour prior to ED visit
  4. * Planned discharge from the ED
  5. * History of osteoarthritis of the affected joint based on radiography performed at index visit or prior available imaging
  1. * Trauma to the affected joint within 30 days
  2. * Injection of affected joint within 60 days
  3. * Prior arthroplasty of the affected joint
  4. * 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)
  5. * Joint pain suspected to be related to rheumatoid arthritis, gout, septic arthritis, or other non-osteoarthritis autoimmune/inflammatory/infectious arthritis
  6. * 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)
  7. * Daily prescription opioid use or active opioid use disorder
  8. * Illicit drug use
  9. * Known allergy/intolerance to ibuprofen/NSAIDs, prednisone, dexamethasone, or other medication precluding ability to participate in one or more study arms
  10. * Other contraindications to ibuprofen/NSAIDs or glucocorticoids
  11. * Planned hospitalization from the ED
  12. * Pregnancy
  13. * Incarceration
  14. * Inability to provide informed consent
  15. * Other conditions that would preclude compliance with the study protocol and medication dosing

Contacts and Locations

Study Contact

Kristen Oliff Oliff
CONTACT
717-812-5075
koliff@wellspan.org
Brent Becker, MD
CONTACT
717-851-4819
bbecker2@wellspan.org

Principal Investigator

Brent Becker, MD
PRINCIPAL_INVESTIGATOR
WellSpan Health

Study Locations (Sites)

WellSpan York Hospital
York, Pennsylvania, 17403
United States

Collaborators and Investigators

Sponsor: WellSpan Health

  • Brent Becker, MD, PRINCIPAL_INVESTIGATOR, WellSpan Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02-24
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • osteoarthritis
  • acute pain
  • glucocorticosteroids
  • emergency department

Additional Relevant MeSH Terms

  • Osteoarthritis
  • Osteoarthritis (OA) of the Knee
  • Osteoarthritis (OA) of the Shoulder
  • Osteoarthritis (OA) of the Hip