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.
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
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)
Parallel
Prednisone
DrugSubjects 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.
Dexamethasone
DrugSubjects 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.
Placebo
DrugSubjects assigned to the Control group will receive oral placebo once a day for 5 days, plus standard ibuprofen 600 mg every 8 hours.
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.
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
Change in Resting Pain Score at 1 Day
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 1.
Change in Resting Pain Score at 7 Days
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 7.
Change in Resting Pain Score at 14 Days
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 14.
Change in Ambulatory/Active Movement Pain Score at 1 Day
Change in ambulatory/active pain score from baseline at time of randomization based on subject-reported numerical ambulatory/active pain score (0-10) for pain in the affected joint obtained during the follow up phone call on Day 1.
Click on the lead sponsor to view all of their trials.
