A Phase 4 interventional study of Prednisone and Dexamethasone in Osteoarthritis, Osteoarthritis (OA) of the Knee and Osteoarthritis (OA) of the Shoulder, sponsored by WellSpan Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by WellSpan Health · Phase 4, Interventional, and Treatment
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:
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:
In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen.
Participants will:
BACKGROUND
Osteoarthritis (OA) constitutes a significant disease burden both within the United States (US) and globally. Recent data shows that upwards of 527 million people worldwide were affected by OA in 2019. Data from 2001-2005 suggests that over 77 million ambulatory visits in the US were attributed to arthritic and rheumatological disorders, of which OA was the predominant etiology. Patients often present to the emergency department (ED) with complaints of acute pain related to OA.
Current guidelines recommend both lifestyle interventions and pharmacological interventions for the treatment of OA-related pain. Oral non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketorolac, and diclofenac remain first-line agents for the treatment of OA-related pain with strong recommendations for this intervention from the American College of Rheumatology/ Arthritis Foundation. In contrast, the evidence for topical NSAID use for the treatment of OA pain is inconsistent regarding their benefit.
Glucocorticosteroids, or glucocorticoids, are commonly used for their anti-inflammatory effects. Intraarticular glucocorticoid injections are a recommended adjunct treatment for OA-related pain refractory to NSAIDs. The majority of clinical practice guidelines support their use in OA with recent data showing significant improvement in pain scores following intraarticular glucocorticoid injections. Although commonly used in the outpatient setting, intraarticular injections for OA are used less frequently in the ED. This is due to the time required to perform the procedure, the need for subsequent follow-up, and technical considerations.
Compared to oral administration, intraarticular glucocorticoid injections have less systemic absorption and the potential for decreased adverse effects; however, oral glucocorticoid regimens have been shown to be well tolerated when given in short courses for acute pain. A Cochrane review examining short-term oral glucocorticoid use for the treatment of radicular low back pain found no association with significant adverse effects, including hyperglycemia.
The use of glucocorticoid injections in OA has been studied robustly, but there has been very little research examining the utility of oral systemic glucocorticoids in the treatment of acute OA-related pain. The current literature is largely limited to OA specifically affecting the hand and does not include ED patients. Dossing et al. found that oral corticosteroids were effective in improving pain, functional status, and quality of life in patients with hand OA when compared to placebo. Similarly, a systematic review noted that oral glucocorticoid use for the treatment of hand OA reduced pain and improved functional status at 4-6 weeks. Dorleijn et al. did not study oral glucocorticoids specifically, but noted that intramuscular injections of glucocorticoids were more effective when compared to placebo for the reduction of negative symptoms in hip OA at 2 weeks and beyond. Surprisingly, no such positive results were observed with intraarticular glucocorticoid injections.
We aim to examine the effectiveness and safety of adding short-term oral systemic glucocorticoids to a standardized NSAID regimen in adult ED patients presenting with acute pain due to OA.
OBJECTIVES
We hypothesize the combination of oral glucocorticoids and NSAIDs will result in improved pain control for acute OA pain compared to NSAIDs alone and will be well tolerated.
STUDY DESIGN
This will be a randomized, controlled, single-blinded, superiority trial consisting of adult patients presenting to the WellSpan York Hospital ED with acute, large joint monoarticular pain related to underlying OA. Informed consent will be obtained by a member of the study team prior to data collection or study procedures.
Patients enrolled in the study will be randomized into one of three groups in a 1:1:1 ratio. Group 1 (control) will receive ibuprofen 600 mg every 8 hours, plus a placebo (no active ingredient) pill daily x 5 days. Group 2 (intervention A) will receive ibuprofen 600 mg every 8 hours, plus prednisone 50 mg daily x 5 days. Group 3 (intervention B) will receive ibuprofen 600 mg every 8 hours x 5 days, plus a single dose of oral dexamethasone 10 mg during the index ED visit, then a placebo (no active ingredient) pill daily x 4 days. Subjects in all three arms will have the option to take oral acetaminophen 975 mg every 8 hours as needed for uncontrolled pain.
Subjects will be followed up by phone at 1 day, 3 days, 7 days, and 14 days and assessed for pain, adverse events, and other outcomes. Chart review will be performed at 14 and 28 days to assess for other adverse events. All research data will be documented on standardized data collection forms.
DATA ANALYSIS
Descriptive statistics will be reported as means/medians with standard deviation/interquartile range for continuous variables and proportions with percentages for categorical variables. Differences in continuous outcome variables between the three study groups will be compared via one way ANOVA. Subsequent pairwise comparisons will utilize the Student T-test for parametric data and the Mann-Whitney U test for non-parametric data with associated 95% confidence intervals. Differences in dichotomous variables between groups will be compared via chi-squared or Fisher's exact tests, as appropriate. Primary analysis will be conducted on an intention-to-treat basis; however, per protocol sensitivity analysis is also planned. Interrater reliability for follow-up data collection from the medical record will be assessed via Cohen's kappa. p \< 0.05 will be considered statistically significant.
POWER CALCULATIONS AND PLANNED SAMPLE SIZE
Power calculations are based on prior published literature on patients presenting with pain related to hip OA. Assuming an approximate baseline pain VAS mean=5/SD=2.2 and an expected mean change in numerical pain score at 72-hours change of 0.5 in the control group and 1.5 in the steroid groups, we need to enroll 59 subjects per arm to achieve 80% power at alpha=0.05. These assumptions also align with the clinically significant margin of difference in pain score (1.0) established in prior studies. Allowing for 5% attrition and need for a total enrollment equally divisible into 3 arms, we plan to enroll a total of 192 subjects (64 per arm, randomized 1:1:1).
RISKS TO SUBJECTS
While NSAIDs and glucocorticoids are very frequently administered medications, there are risks associated with their use. NSAIDs have been associated with gastric/peptic irritation/ulcers, renal adverse effects (kidney injury, electrolyte/fluid disorders, renal papillary necrosis, and interstitial nephritis) and cardiovascular adverse effects (myocardial infarction, thromboembolic events, and atrial fibrillation), as well as hepatic or hematologic effects; however, significant adverse effects from ibuprofen are rare, particularly when taken in a short course in the absence of contraindications. Ibuprofen is available over the counter without a prescription and is generally very well tolerated.
Glucocorticoids have been associated with adverse effects affecting the musculoskeletal system (osteoporosis, myopathy, osteonecrosis), endocrine system (elevated blood glucose, cushingoid features, weight gain, hirsutism/alopecia), cardiovascular system (hypertension, fluid retention, arrhythmias), and gastrointestinal system (ulcers, GIB). They are also associated with increased rates of infection and neuropsychiatric effects, such as anxiety, depression, psychosis, and sleep disturbances. However, the incidence and severity of these effects are linked to the glucocorticoid dose and duration; short courses are very commonly used in clinical practice and generally well tolerated.
There is a slight risk of the participants' privacy or confidentiality being breached. Standard precautions will be taken to ensure privacy and confidentiality are maintained during the study. There are no additional required study visits.
COSTS AND COMPENSATION
No compensation will be given to participants. There will be no research-related costs to the patient. Study medications will be provided to participants at no cost.
POTENTIAL BENEFITS TO SUBJECTS
Subjects may receive clinical benefit from the additional anti-inflammatory effect provided by glucocorticoids; however, determining the effectiveness of glucocorticoids in this clinical application is the purpose of the study. Subjects may not directly benefit from participation but may help to improve the care of patients suffering from acute OA-related pain in the future.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 192 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →WellSpan Health is the lead sponsor of 30 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
Subjects 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.
Time frame: 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
Time frame: 28 days
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.
Time frame: 1 day (24 hours)
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.
Time frame: 7 days
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.
Time frame: 14 days
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.
Time frame: 1 day (24 hours)
Change in Ambulatory/Active Movement Pain Score at 3 Days
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 3.
Time frame: 3 days (72 hours)
Change in Ambulatory/Active Movement Pain Score at 7 Days
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 7.
Time frame: 7 days
Change in Ambulatory/Active Movement Pain Score at 14 Days
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 14.
Time frame: 14 days
Use of Rescue Medication for Pain (Acetaminophen)
The total number of acetaminophen doses taken as needed for uncontrolled pain since discharge from the emergency department, as reported by the subject during the follow up phone call on Day 14.
Time frame: 14 days
Plan to share: No — The study, including data collection and analysis is being conducted at a single site.
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Studies of the drugs tested here: Prednisone · Dexamethasone
WellSpan Health