Ketorolac vs Corticosteroid Injections for Joint Pain

Overseen By Michael Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: McMaster University

Disqualifiers: Back surgery, Depression, Infections, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an injection of ketorolac, a non-steroidal anti-inflammatory drug (NSAID), can relieve pain in the sacroiliac (SI) joint as effectively as standard corticosteroid injections, which may harm the joint with repeated use. The researchers aim to determine if ketorolac can provide the same pain relief without causing joint damage and at a lower cost. This could enable more frequent injections for better pain management. Individuals with SI joint pain for at least three months and specific positive tests for this condition might be suitable candidates for the trial. As an Early Phase 1 trial, this research focuses on understanding how ketorolac works in people, offering participants the chance to contribute to groundbreaking pain management solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ketorolac injections are generally safe for treating joint pain. One study found that ketorolac causes less damage to joint cells than corticosteroid injections. Another study showed that ketorolac provides pain relief similar to corticosteroids. Some patients experienced temporary knee pain shortly after the injection.

For methylprednisolone, a type of corticosteroid, studies indicate it reduces pain and improves joint movement. However, repeated use of corticosteroids can harm joints over time.

In summary, both treatments effectively relieve pain. Ketorolac might be a safer choice for long-term use due to its reduced joint damage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a potentially faster and more targeted approach to relieving joint pain. Most current treatments for joint pain include oral medications like NSAIDs or corticosteroid injections. Ketorolac, a nonsteroidal anti-inflammatory drug, is being tested as an injection directly into the joint, which might provide quicker pain relief compared to oral options. Meanwhile, methylprednisolone injections are a standard approach, but this direct comparison in the trial can help determine if ketorolac is a viable alternative. The use of ultrasound guidance for both injections may also enhance precision and effectiveness, potentially improving outcomes for patients.

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

This trial will compare the effectiveness of ketorolac and corticosteroid injections for joint pain. Research has shown that both ketorolac and corticosteroid injections relieve joint pain and improve movement. One study found that ketorolac injections worked as well as corticosteroid injections in reducing pain and improving function. Another study showed that patients who received ketorolac had lower pain scores soon after treatment. While corticosteroids are typically the standard for joint injections, ketorolac offers a good alternative because it doesn't risk joint damage from frequent use. This makes ketorolac a promising option for managing joint pain. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with sacroiliac joint pain lasting at least 3 months and positive physical tests confirming the condition. It's not suitable for those with previous back surgery, leg pain due to nerve issues, risks from NSAIDs like stomach bleeds or kidney failure, heart or liver problems, muscle pain syndromes unrelated to SI joints, depression, allergies to study drugs, infections or cognitive issues affecting consent.

Inclusion Criteria

I am older than 18 years.

I have had sacroiliac joint pain for at least 3 months.

I have tested positive for SI joint pain in at least 3 special exams.

Exclusion Criteria

My back pain is due to disc problems.

I have been diagnosed with depression.

I do not have any infections, especially where needles might be used.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ultrasound guided SI joint injections with either ketorolac or corticosteroid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain relief and safety at 2, 6, and 12 weeks post-injection

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac Injection
• Methylprednisolone Injection

Trial Overview The study compares two types of injections for treating SI joint pain: Ketorolac (a non-steroidal anti-inflammatory drug that doesn't damage joints) and Methylprednisolone (a corticosteroid which is standard but can harm joints if used often). Pain relief will be measured after 2, 6 and 12 weeks post-injection using ultrasound guidance.

How Is the Trial Designed?

Group I: Corticosteroid Active Control 1 Intervention

Patients will receive ultrasound guided corticosteroid injection to see pain relief after injection

Group II: Ketorolac Active Control 1 Intervention

Patients will receive ultrasound guided ketorolac injection to see pain relief after injection

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Local corticosteroid injections are generally safe and can effectively manage symptoms in conditions like rheumatoid arthritis and knee osteoarthritis, providing relief for up to three months in some cases.

While these injections can help with acute flare-ups and certain symptoms, they do not significantly prevent joint damage or erosive changes, and their use should complement other treatments like physical therapy and disease-modifying drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroids. An updated assessment. Gray, RG., Gottlieb, NL.[2006]

Ketorolac can cause serious side effects like gastrointestinal bleeding and renal impairment, but the risk of these events has decreased since dosage guidelines were revised, making it slightly safer than opioids for pain management.

The risk of adverse effects increases with higher doses, prolonged use beyond 5 days, or in vulnerable populations such as the elderly, highlighting the importance of careful patient selection and adherence to prescribing guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimising the adverse effects of ketorolac. Reinhart, DI.[2018]

A 40 mg intra-articular injection of methylprednisolone acetate (MPA) can provide clinical benefits for knee osteoarthritis symptoms, but careful consideration of factors like pain severity and individual patient circumstances is crucial for effectiveness.

There are significant safety concerns and contraindications associated with MPA injections, especially regarding patients on anticoagulants, highlighting the need for individualized treatment plans and thorough risk-benefit evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. McCrum, C.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7153200/

Effect of Intra-articular Ketorolac Versus Corticosteroid ... The current study demonstrated that intra-articular ketorolac and corticosteroid injections produce the same pain relief and functional improvement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11149950/

Ketorolac Injections for Musculoskeletal Conditions Five patients in the ketorolac group experienced focal knee pain for approximately 8 hours after the injections. Stalman et al examined local metabolism ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088354031630153X

Economic Impact of Ketorolac vs Corticosteroid Intra ... This study showed that ketorolac intra-articular injection decreases pain and increases function similarly to corticosteroid. Corticosteroid intra-articular ...

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02833-4

Efficacy of intra-articular ketorolac for pain control in ... Meta-analysis revealed that patients receiving intra-articular ketorolac had significantly lower pain scores at 2–4 h.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03694821

Study Details | NCT03694821 | Knee Injection RCT The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pmrj.13387

Corticosteroid versus ketorolac injection for treatment of ... In conclusion, IA ketorolac is safe, less toxic to chondrocytes, and has a similar efficacy profile to that of corticosteroid injections in the ...

7. rapm.bmj.com rapm.bmj.com/content/early/2025/02/26/rapm-2024-105656

Use and safety of corticosteroid injections in joints and ... This guideline focuses on the safety and efficacy of corticosteroid joint injections for managing joint chronic pain in adults.