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

NCT06603662 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2207448
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

osteoarthritis; acute pain; glucocorticosteroids; emergency department

Outcome Measures

Primary Outcomes (2)

• Change in Resting Pain Score at 3 Days (Effectiveness Outcome)

  Change in resting pain score from baseline at time of randomization based on subject-reported numerical resting pain score (0-10) for pain in the affected joint obtained during the follow up phone call on Day 3.

  3 days (72 hours)

• Adverse Events (Safety Outcome)

  Occurrence of adverse events reported during follow up phone calls on Day 1, 3, 7 and 14 or during chart review on Day 14 and 28, including: * Hyperglycemia requiring discontinuation of the study medication * Diabetic ketoacidosis or hospitalization for diabetes-related process * Bleeding events, including gastrointestinal bleeding (GIB) * Abdominal pain requiring discontinuation of the study medication * Worsening renal function requiring discontinuation of the study medication * Other adverse events necessitating discontinuation of study medication * Repeat visit to an emergency department * Hospitalization * Death

  28 days

Secondary Outcomes (8)

• Change in Resting Pain Score at 1 Day

  1 day (24 hours)

• Change in Resting Pain Score at 7 Days

  7 days

• Change in Resting Pain Score at 14 Days

  14 days

• Change in Ambulatory/Active Movement Pain Score at 1 Day

  1 day (24 hours)

• Change in Ambulatory/Active Movement Pain Score at 3 Days

  3 days (72 hours)

Study Arms (3)

Intervention A - Prednisone

ACTIVE COMPARATOR

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.

Drug: Prednisone

Intervention B - Dexamethasone

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Control - Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Prednisone DRUG

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.

Intervention A - Prednisone

Dexamethasone DRUG

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.

Intervention B - Dexamethasone

Placebo DRUG

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

Control - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

WellSpan York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Related Publications (11)

• Estee MM, Cicuttini FM, Page MJ, Butala AD, Wluka AE, Hussain SM, Wang Y. Efficacy of corticosteroids for hand osteoarthritis - a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2022 Jul 13;23(1):665. doi: 10.1186/s12891-022-05619-9.

  PMID: 35831847 BACKGROUND

• Chou R, Pinto RZ, Fu R, Lowe RA, Henschke N, McAuley JH, Dana T. Systemic corticosteroids for radicular and non-radicular low back pain. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012450. doi: 10.1002/14651858.CD012450.pub2.

  PMID: 36269125 BACKGROUND

• Phillips M, Bhandari M, Grant J, Bedi A, Trojian T, Johnson A, Schemitsch E. 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. Orthop J Sports Med. 2021 Aug 31;9(8):23259671211030272. doi: 10.1177/23259671211030272. eCollection 2021 Aug.

  PMID: 34485586 BACKGROUND

• Juni P, Hari R, Rutjes AW, Fischer R, Silletta MG, Reichenbach S, da Costa BR. Intra-articular corticosteroid for knee osteoarthritis. Cochrane Database Syst Rev. 2015 Oct 22;2015(10):CD005328. doi: 10.1002/14651858.CD005328.pub3.

  PMID: 26490760 BACKGROUND

• Dorleijn DMJ, Luijsterburg PAJ, Reijman M, Kloppenburg M, Verhaar JAN, Bindels PJE, Bos PK, Bierma-Zeinstra SMA. Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial. Ann Rheum Dis. 2018 Jun;77(6):875-882. doi: 10.1136/annrheumdis-2017-212628. Epub 2018 Mar 7.

  PMID: 29514801 BACKGROUND

• Dossing A, Nielsen SM, Kroon FP, Balsby IM, Tarp S, Kloppenburg M, Stamp L, Haugen IK, Altman RD, Henriksen M, Boesen M, Bliddal H, Berg S, Christensen R. Comparative effectiveness of pharmacological interventions for hand osteoarthritis: a systematic review and network meta-analysis of randomised trials. RMD Open. 2023 Aug;9(3):e003030. doi: 10.1136/rmdopen-2023-003030.

  PMID: 37734873 BACKGROUND

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Feb;72(2):149-162. doi: 10.1002/acr.24131. Epub 2020 Jan 6.

  PMID: 31908149 BACKGROUND

• Long H, Liu Q, Yin H, Wang K, Diao N, Zhang Y, Lin J, Guo A. Prevalence Trends of Site-Specific Osteoarthritis From 1990 to 2019: Findings From the Global Burden of Disease Study 2019. Arthritis Rheumatol. 2022 Jul;74(7):1172-1183. doi: 10.1002/art.42089. Epub 2022 Jun 2.

  PMID: 35233975 BACKGROUND

• Irizarry E, Restivo A, Salama M, Davitt M, Feliciano C, Cortijo-Brown A, Friedman BW. A randomized controlled trial of ibuprofen versus ketorolac versus diclofenac for acute, nonradicular low back pain. Acad Emerg Med. 2021 Nov;28(11):1228-1235. doi: 10.1111/acem.14321. Epub 2021 Jun 30.

  PMID: 34133820 BACKGROUND

• Young SE, Bothwell JD, Walsh RM. Safely Managing Acute Osteoarthritis in the Emergency Department: An Evidence-Based Review. J Emerg Med. 2016 Dec;51(6):648-657. doi: 10.1016/j.jemermed.2016.05.052. Epub 2016 Jul 29.

  PMID: 27480348 BACKGROUND

• Sacks JJ, Luo YH, Helmick CG. Prevalence of specific types of arthritis and other rheumatic conditions in the ambulatory health care system in the United States, 2001-2005. Arthritis Care Res (Hoboken). 2010 Apr;62(4):460-4. doi: 10.1002/acr.20041.

  PMID: 20391499 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Acute Pain; Emergencies

Interventions

Prednisone; Dexamethasone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• Brent Becker, MD

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Oliff Oliff

CONTACT

717-812-5075; koliff@wellspan.org

Brent Becker, MD

CONTACT

717-851-4819; bbecker2@wellspan.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blinded controlled trial

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)