192 Participants Needed

Oral Steroids for Osteoarthritis Pain

KO
BB
Overseen ByBrent Becker, MD
Prior Safety DataThis treatment has passed at least one previous human trial

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?

BB

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

I have severe joint pain in my knee, hip, or shoulder due to arthritis.
I started feeling more pain than usual less than 3 days ago.
My X-rays show I have osteoarthritis in my joint.
See 1 more

Exclusion Criteria

I have had joint replacement surgery on the affected joint.
Illicit drug use
I cannot take ibuprofen/NSAIDs or steroids due to other health reasons.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either placebo, prednisone, or dexamethasone along with ibuprofen for 5 days

5 days
1 visit (in-person) for initial treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment through follow-up phone calls

4 weeks
Phone calls at 1, 3, 7, and 14 days

Extended Follow-up

Additional monitoring for adverse events through chart review

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Prednisone
Trial Overview The trial is checking if oral steroids (Prednisone or Dexamethasone) plus ibuprofen relieve osteoarthritis pain better than placebo pills with ibuprofen. Participants are randomly assigned to one of three groups and followed up for two weeks.
How Is the Trial Designed?
3Treatment groups
Active Control
Placebo Group
Group I: Intervention A - PrednisoneActive Control1 Intervention
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.
Group II: Intervention B - DexamethasoneActive Control1 Intervention
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.
Group III: Control - PlaceboPlacebo Group1 Intervention
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.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Dexamethasone for:
  • Inflammation
  • Allergic reactions
  • Respiratory diseases
  • Skin conditions
  • Eye diseases
  • Immune system disorders
🇺🇸
Approved in United States as Dexamethasone for:
  • Inflammatory conditions
  • Allergic states
  • Respiratory diseases
  • Blood disorders
  • Neoplastic diseases
  • Nervous system disorders
🇨🇦
Approved in Canada as Dexamethasone for:
  • Inflammation
  • Allergic reactions
  • Respiratory diseases
  • Skin conditions
  • Eye diseases
🇯🇵
Approved in Japan as Dexamethasone for:
  • Inflammatory conditions
  • Allergic states
  • Respiratory diseases
  • Blood disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

WellSpan Health

Lead Sponsor

Trials
32
Recruited
2,005,000+

Published Research Related to This Trial

Oral dexamethasone significantly reduced postoperative pain scores in patients undergoing total knee arthroplasty, particularly on postoperative days 2, 3, and 4, compared to a placebo group.
Despite the pain reduction, there were no significant differences in opioid usage, nausea, vomiting, or other complications between the dexamethasone and placebo groups, suggesting a favorable safety profile for this treatment.
The AAHKS Clinical Research Award: Oral Dexamethasone Following Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial.Shaw, JH., Wesemann, LD., Banka, TR., et al.[2023]
In a double-blind study of 39 patients with prolapsed lumbar disc symptoms, dexamethasone did not show a statistically significant advantage over placebo, with only 19 patients receiving dexamethasone experiencing improvement compared to 20 patients on placebo.
Despite some patients showing improvement, 50% of those who did improve in both groups experienced recurrences of symptoms within 3 months, suggesting that neither treatment provided lasting relief.
Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc.Hedeboe, J., Buhl, M., Ramsing, P.[2019]
In a study involving 73 patients undergoing percutaneous epidural adhesiolysis, dexamethasone sodium phosphate (DSP) demonstrated non-inferiority to triamcinolone acetate (TA) in reducing pain and improving function at the 6-month follow-up, with success rates of 62.5% for DSP compared to 45.2% for TA.
At 3 months, while DSP showed a higher mean percent decrease in pain scores (46.1%) compared to TA (42.4%), non-inferiority was not established until the 6-month mark, indicating that DSP may provide longer-lasting benefits in pain management.
Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids.Cho, S., Park, HS.[2018]

Citations

The AAHKS Clinical Research Award: Oral Dexamethasone Following Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. [2023]
Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. [2016]
The in vivo effects of intraarticular corticosteroid injections on cartilage lesions, stromelysin, interleukin-1, and oncogene protein synthesis in experimental osteoarthritis. [2022]
Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. [2019]
Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. [2018]
The chondrotoxicity of single-dose corticosteroids. [2021]
Double-blind study with liposteroid in rheumatoid arthritis. [2016]
8.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Treatment with megadoses of dexaven (dexamethasone) versus methypred (6-methylprednisolone) of patients with rheumatoid arthritis]. [2013]
The current relevance and use of prednisone in rheumatoid arthritis. [2015]
[Study on toxicity of halopredone acetate. (I) Acute toxicity study in mice and rats]. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Osteo-arthritis of the hip treated by intraneural injection. A simplified technique for the relief of intractable osteo-arthritic pain. [2019]
12.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Intra-articular Treatment with Triamcinolone Hexacetonide Associated with Gold Nanoparticles Reduces Cartilage Degeneration in an Animal Model of Osteoarthritis. [2023]
Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]
Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]
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