Oral Steroids for Osteoarthritis Pain

Overseen By Brent Becker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: WellSpan Health

Must not be taking: Glucocorticoids, NSAIDs, Opioids, others

Disqualifiers: Coronary artery disease, Kidney disease, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 5 days

192 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 11 12 13 14}

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

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.

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.

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?

Group I: Intervention A - Prednisone Active Control 1 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 - Dexamethasone Active Control 1 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 - Placebo Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. Cho, S., Park, HS.[2018]

In a study evaluating the effects of various corticosteroids on human chondrocyte viability, betamethasone sodium phosphate and betamethasone acetate were found to significantly decrease chondrocyte viability after a single injection, indicating potential chondrotoxicity.

Triamcinolone acetonide also showed signs of chondrotoxicity, but only in one trial, while betamethasone consistently caused significant cell death over a 14-day period, suggesting it should be used with caution in joint injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The chondrotoxicity of single-dose corticosteroids. Dragoo, JL., Danial, CM., Braun, HJ., et al.[2021]

Prednisone has been effectively used for over 60 years to treat inflammatory conditions like rheumatoid arthritis, and recent clinical trials have shifted its use towards long-term low-dose regimens.

Current research is focusing on the safety and effectiveness of these low-dose treatments, including insights from the 2nd Circadian Administration of Prednisone trial, which explores the benefits of modified-release formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current relevance and use of prednisone in rheumatoid arthritis. Krasselt, M., Baerwald, C.[2015]

A new treatment for hip osteoarthritis using an intraneural injection of Triamcinolone Hexacetonide shows better results than traditional systemic or intra-articular steroid methods.

This method provides rapid relief from muscle spasms and pain, supporting findings from previous studies that highlight its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteo-arthritis of the hip treated by intraneural injection. A simplified technique for the relief of intractable osteo-arthritic pain. Pybus, PK.[2019]

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, with 78% reporting improvement at week 1 compared to 49% in the placebo group.

The effectiveness of THA was particularly enhanced in patients with joint effusion and those who had synovial fluid aspirated during the injection, indicating that these factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Gaffney, K., Ledingham, J., Perry, JD.[2022]

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The AAHKS Clinical Research Award: Oral Dexamethasone Following Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

The in vivo effects of intraarticular corticosteroid injections on cartilage lesions, stromelysin, interleukin-1, and oncogene protein synthesis in experimental osteoarthritis. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Effects of using dexamethasone and placebo in the treatment of prolapsed lumbar disc. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Percutaneous Epidural Adhesiolysis with Epidural Steroid Injection: A Non-inferiority Test of Non-particulate Steroids Versus Particulate Steroids. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

The chondrotoxicity of single-dose corticosteroids. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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]

9. England pubmed.ncbi.nlm.nih.gov

The current relevance and use of prednisone in rheumatoid arthritis. [2015]

10. Japan pubmed.ncbi.nlm.nih.gov

[Study on toxicity of halopredone acetate. (I) Acute toxicity study in mice and rats]. [2019]

11. United States pubmed.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 Emirates pubmed.ncbi.nlm.nih.gov

Intra-articular Treatment with Triamcinolone Hexacetonide Associated with Gold Nanoparticles Reduces Cartilage Degeneration in an Animal Model of Osteoarthritis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]