Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06603662

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

Led by WellSpan Health · Updated on 2025-03-27

192

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain relief effects of combining oral glucocorticoids (steroids) with standard pain medications compared to pain medications alone in adults who visit the emergency department with joint pain caused by osteoarthritis. This study aims to assess both the effectiveness and safety of short-term oral glucocorticoid use for this condition. Osteoarthritis is a common cause of joint pain and disability, with many patients seeking emergency care for acute flare-ups. Participants will be randomly assigned to one of three groups: one receiving placebo pills with ibuprofen, one receiving prednisone with ibuprofen, and one receiving a single dose of dexamethasone followed by placebo pills with ibuprofen. All groups may use acetaminophen as needed for additional pain relief. Treatment lasts five days, with glucocorticoids given either daily or as a single dose depending on the group. Throughout the study, participants will report their pain levels and medication use via follow-up phone calls at 1, 3, 7, and 14 days. Researchers will monitor safety by tracking any adverse events for up to 28 days and reviewing medical records. The main outcome measured is the change in resting pain score at three days after starting treatment, along with safety assessments. This study will help determine if adding glucocorticoids to standard pain medication improves pain control in acute osteoarthritis joint pain.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute monoarticular joint pain in the native knee, hip, or shoulder related to osteoarthritis
  • Pain started less than 72 hours before the emergency department visit
  • Planned discharge from the emergency department
  • History of osteoarthritis in the affected joint confirmed by recent or prior imaging
Not Eligible

You will not qualify if you...

  • Trauma to the affected joint within 30 days
  • Injection of the affected joint within 60 days
  • Previous joint replacement surgery of the affected joint
  • History of coronary artery disease, severe gastrointestinal bleeding, peptic ulcers, chronic kidney disease with GFR under 30, or bleeding disorders
  • Joint pain suspected to be caused by rheumatoid arthritis, gout, infection, or other autoimmune/inflammatory arthritis
  • Chronic use of glucocorticoids or NSAIDs before the visit
  • Daily prescription opioid use or active opioid use disorder
  • Illicit drug use
  • Allergy or intolerance to ibuprofen, prednisone, dexamethasone, or other study medications
  • Other contraindications to ibuprofen or glucocorticoids
  • Planned hospital admission from the emergency department
  • Pregnancy
  • Incarceration
  • Inability to provide informed consent
  • Other conditions preventing adherence to the study protocol and medication use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 days

Participants receive a 5-day course of oral medications including ibuprofen and either prednisone, dexamethasone, or placebo to treat acute osteoarthritis pain.

1 baseline visit (in-person) during the emergency department visit

Follow-up

Duration - 28 days

Participants are followed up by phone and chart review to assess pain, adverse events, and other outcomes after treatment.

Phone follow-up at 1, 3, 7, and 14 days; chart review at 14 and 28 days

Trial Site Locations

Total: 1 location

1

WellSpan York Hospital

York, Pennsylvania, United States, 17403

Actively Recruiting

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Research Team

K

Kristen Oliff Oliff

B

Brent Becker, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Efficacy of corticosteroids for hand osteoarthritis - a systematic review and meta-analysis of randomized controlled trials.

Mahnuma Mahfuz Estee, Flavia M Cicuttini, Matthew J Page...

https://pubmed.ncbi.nlm.nih.gov/35831847

A Systematic Review of Current Clinical Practice Guidelines on Intra-articular Hyaluronic Acid, Corticosteroid, and Platelet-Rich Plasma Injection for Knee Osteoarthritis: An International Perspective.

Mark Phillips, Mohit Bhandari, John Grant...

https://pubmed.ncbi.nlm.nih.gov/34485586

Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial.

Desirée M J Dorleijn, Pim A J Luijsterburg, Max Reijman...

https://pubmed.ncbi.nlm.nih.gov/29514801

Comparative effectiveness of pharmacological interventions for hand osteoarthritis: a systematic review and network meta-analysis of randomised trials.

Anna Døssing, Sabrina Mai Nielsen, Féline Pb Kroon...

https://pubmed.ncbi.nlm.nih.gov/37734873

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.

Sharon L Kolasinski, Tuhina Neogi, Marc C Hochberg...

https://pubmed.ncbi.nlm.nih.gov/31908149

Prevalence Trends of Site-Specific Osteoarthritis From 1990 to 2019: Findings From the Global Burden of Disease Study 2019.

Huibin Long, Qiang Liu, Heyong Yin...

https://pubmed.ncbi.nlm.nih.gov/35233975

A randomized controlled trial of ibuprofen versus ketorolac versus diclofenac for acute, nonradicular low back pain.

Eddie Irizarry, Andrew Restivo, Maha Salama...

https://pubmed.ncbi.nlm.nih.gov/34133820