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

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.

Timeline

Start

2025-02-24

Primary completion

2027-10

Completion

2027-12

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications