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?

This trial aims to determine if adding steroids to regular pain medications reduces osteoarthritis joint pain more effectively than pain medications alone. Researchers are testing steroids like prednisone and dexamethasone (both oral corticosteroids) for their ability to decrease pain and inflammation. Participants will be divided into three groups: one receiving a placebo (inactive pill), another receiving prednisone, and the last group receiving dexamethasone. Individuals experiencing sudden, severe joint pain from osteoarthritis in the knees, hips, or shoulders, with pain lasting less than 72 hours, might be suitable candidates. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment benefits more patients.

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.

What is the safety track record for these treatments?

Research has shown that prednisone is generally safe for short-term use. One study found that taking 10 mg of prednisolone (a drug similar to prednisone) for 6 weeks was effective and safe for people with hand osteoarthritis. However, using oral corticosteroids for more than 90 days can slightly increase the risk of side effects.

For dexamethasone, research indicates it can help reduce pain and swelling. One study found that a single dose lowered pain without major side effects. Another study showed that using it during surgery resulted in less pain and fewer side effects compared to not using it.

This trial is in its final phase, which usually means earlier studies have already shown the treatments to be safe. The current focus is on confirming these results and assessing how well the treatments work. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for osteoarthritis pain because they explore the use of oral steroids, which could offer faster relief. Unlike typical options like NSAIDs and acetaminophen that mainly manage symptoms, prednisone and dexamethasone target inflammation at its source. Prednisone is taken daily, allowing for consistent anti-inflammatory effects, while a single dose of dexamethasone could provide a rapid and prolonged response. This approach might offer quicker and potentially more effective pain management, which is a significant advancement for those suffering from osteoarthritis.

What evidence suggests that this trial's treatments could be effective for osteoarthritis pain?

Research has shown that certain steroids, such as prednisone and dexamethasone, can reduce pain and improve movement in people with osteoarthritis. This trial will assign participants to different treatment arms to evaluate these effects. Participants in the Intervention A group will receive prednisone, which studies have found can lessen pain and stiffness in conditions similar to osteoarthritis. Meanwhile, those in the Intervention B group will receive dexamethasone, which significantly reduced pain after surgeries, suggesting it might also help with osteoarthritis pain. Both treatments may offer short-term pain relief, which is important for those with osteoarthritis. Overall, using these steroids alongside standard pain medications might provide better pain relief than using pain medications alone. ^{1 3 4 6 7}

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

Pregnancy

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

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 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]

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 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]

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

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a double-edged sword in the treatment of osteoarthritis

DEX significantly reduced inflammation but also ECM production in inflamed chondrocytes. At 24 h, DEX treatment led to 168 differentially ...

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DxPh resulted in a greater improvement in pain and function in patients with knee OA than therapeutic ultrasound combined with exercise and TENS.

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INTRA-ARTICULAR DEXAMETHASONE TO INHIBIT THE ...

A single, intra-articular injection of dexamethasone into the wrist shows promise in preventing PTOA after intra-articular fracture of the distal radius.

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Safety monitoring included serial radiographs and plasma dexamethasone concentrations. Subjects experienced an average 3.8 point reduction in ...