Methylprednisolone for Osteoarthritis

Overseen By Jacqueline Lenahan

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Columbia University

Must not be taking: Corticosteroids, Opiates

Disqualifiers: Liver disease, Renal disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 days

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether methylprednisolone, a corticosteroid, can reduce pain and the need for opioids after knee replacement surgery. The goal is to determine if this medication can ease recovery by decreasing pain and nausea. Individuals with osteoarthritis undergoing their first knee replacement may be suitable candidates, particularly if they plan to return home the day after surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants an opportunity to contribute to early-stage medical research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using chronic corticosteroids or opiates, you cannot participate in the trial.

Is there any evidence suggesting that methylprednisolone is likely to be safe for humans?

Research has shown that methylprednisolone is usually well-tolerated and can help reduce pain after surgery. One study found that it significantly lowered pain levels and the need for painkillers after total knee replacement surgery, resulting in fewer opioids used and reduced side effects like nausea.

Although this trial is in its early stages, methylprednisolone is already used in other treatments, indicating that its safety is fairly well understood. However, like any medication, it carries some risk of side effects, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Methylprednisolone is unique because it offers a new approach for managing osteoarthritis pain. While most treatments focus on long-term relief through physical therapy and NSAIDs like ibuprofen, methylprednisolone is a corticosteroid that works quickly to reduce inflammation and pain. Researchers are excited because this oral steroid might provide faster pain relief in just a few days, potentially helping patients who need immediate symptom management. Additionally, the six-day tapering schedule could minimize potential side effects, making it a promising alternative for those who struggle with chronic pain management.

What evidence suggests that methylprednisolone might be an effective treatment for osteoarthritis?

Research shows that methylprednisolone can reduce pain and improve movement for people with knee osteoarthritis. Studies where this medication is injected directly into the joint have demonstrated significant pain relief, although the effects are short-lived. This steroid reduces swelling, which eases pain. In this trial, some participants will receive oral methylprednisolone as part of their treatment. While most studies focus on injections, taking it as a pill might also help by reducing swelling throughout the body. More research is needed to confirm the pill form's effectiveness for pain after surgery, but its general ability to relieve pain makes it a promising option. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with osteoarthritis undergoing primary total knee arthroplasty. Participants must be able to go home by the day after surgery to start medication and agree to randomization. Excluded are those who are immunocompromised, have chronic corticosteroid or opiate use, severe systemic disease (ASA score ≥ 4), certain medical conditions like heart failure or psychosis, known allergy to methylprednisolone, or inability to take oral meds.

Inclusion Criteria

Willingness to undergo randomization

I am over 18 years old.

I will be home by the day after my surgery to start my medication.

Exclusion Criteria

I have a weakened immune system.

I have been using corticosteroids or opiates regularly before surgery.

My health is severely limited by my illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a six-day oral methylprednisolone taper in addition to standard multimodal pain management

6 days

Daily visits for 6 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-10 weeks

Visits at 2-3 weeks and 6-10 weeks post-operative

What Are the Treatments Tested in This Trial?

Interventions

• Methylprednisolone

Trial Overview The study tests if taking a decreasing dose of oral methylprednisolone can reduce pain, opioid need, and nausea after knee replacement surgery. Patients will be randomly assigned to receive this steroid tapering regimen post-surgery and their recovery outcomes will be compared.

How Is the Trial Designed?

Group I: Patients receiving oral methylprednisolone Experimental Treatment 1 Intervention

Patients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management

Group II: Patients receiving standard pain management without the taper Active Control 1 Intervention

Patients receiving standard pain management without the taper

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5908555/

Intra-articular injection of methylprednisolone for reducing ... Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118306265

Review Comparison of intra-articular hyaluronic acid and ... The present meta-analysis indicated that both HA and methylprednisolone were effective in reducing pain in knee OA and HA showed comparable effect to ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/04130/intra_articular_injection_of_methylprednisolone.8.aspx

Intra-articular injection of methylprednisolone for... : Medicine Intra-articular methylprednisolone injection was associated with an improved pain relief and physical function in patients with knee osteoarthritis.

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05574-w

Long-term effectiveness of intra-articular injectables in ... Corticosteroids are effective for short-term pain relief but have limited mid- to long-term benefits. A meta-analysis by Jevsevar et al. ...

5. oarsijournal.com oarsijournal.com/article/S1063-4584(24)01389-X/fulltext

Effectiveness and safety of intra-articular interventions for ... Pain and function outcomes were analyzed at 2, 6, 12, 24, and 52 weeks post-randomization, and presented as standardized mean differences (SMDs) ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1743919118315450

The efficacy and safety of methylprednisolone for pain ... Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption and opioid-related adverse effects after TKA.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06163755

Comparison of Efficacy of Intra-articular Morphine vs ... For the secondary efficacy and safety outcomes, the testing level will be 0.05. ... Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in ...