Oral Steroids for Osteoarthritis Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using glucocorticoids or NSAIDs regularly, or if you have certain medical conditions or allergies. It's best to discuss your current medications with the trial team.
Is it safe to use oral steroids like dexamethasone and prednisone for osteoarthritis pain?
Oral steroids like dexamethasone and prednisone have been used safely for many years in treating conditions like rheumatoid arthritis. Studies show that they can be effective with a low frequency of side effects, especially when used in low doses over a long period. However, as with any medication, there can be side effects, so it's important to discuss with a doctor.12345
How is the drug Dexamethasone, Prednisone unique for osteoarthritis pain?
Dexamethasone and Prednisone are oral steroids that may offer a different approach compared to the more common intra-articular (injected directly into the joint) treatments like Triamcinolone Hexacetonide, which are typically used for osteoarthritis. This oral administration could provide a more convenient option for patients who prefer not to have injections.678910
What data supports the effectiveness of the drug for osteoarthritis pain?
Research shows that corticosteroids, like dexamethasone, can reduce pain and inflammation in joint-related conditions, as seen in studies involving joint surgeries and experimental osteoarthritis. This suggests they might help with osteoarthritis pain by reducing inflammation in the joints.711121314
Who Is on the Research Team?
Brent Becker, MD
Principal Investigator
WellSpan Health
Are You a Good Fit for This Trial?
Adults with joint pain from osteoarthritis visiting the emergency department can join. They'll be testing if adding steroids to standard pain meds helps more than just pain meds alone.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo, prednisone, or dexamethasone along with ibuprofen for 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment through follow-up phone calls
Extended Follow-up
Additional monitoring for adverse events through chart review
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Prednisone
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
WellSpan Health
Lead Sponsor