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

20 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drugs Ketorolac and Methylprednisolone for joint pain?

Research shows that methylprednisolone injections can help reduce pain in conditions like osteoarthritis of the knee, providing short to medium-term relief. This suggests that methylprednisolone might also be effective for joint pain in other areas. ^{1 2 3 4 5}

Is it safe to use ketorolac or corticosteroid injections for joint pain?

Ketorolac can cause side effects like stomach bleeding, kidney issues, and allergic reactions, especially in high doses or long-term use. Corticosteroid injections may lead to joint infections and cartilage damage if used too often. Both treatments require careful consideration of risks and benefits. ^{6 7 8 9 10}

How does the drug Ketorolac differ from corticosteroid injections for joint pain?

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain, while corticosteroid injections like methylprednisolone work by suppressing the immune response to reduce inflammation. This makes Ketorolac unique as it offers a different mechanism of action compared to corticosteroids, which are often used for their long-term pain relief in joint conditions. ^{3 4 11 12 13}

What is the purpose of this trial?

This study will contribute to the current literature that have compared joint injections with steroid versus ketorolac providing evidence for the use of ketorolac for SI joint pain. Currently steroid is the clinical standard for joint injections, however with repetitive use, steroid injections can damage the joint. Ketorolac is an alternative anti-inflammatory medication that does not cause the same joint damage and at a cheaper cost than steroid. The investigators hypothesize that ultrasound guided SI joint injections utilizing ketorolac provide the same pain relief as corticosteroid SI joint injections measured at 2, 6 and 12 weeks post injection. This would allow more frequent injections to control pain at a decreased cost to the healthcare system.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 1: Clinical Effectiveness. [2018]

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

The efficacy and safety of methylprednisolone for pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials. [2018]

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

Evaluation of the diffusion of corticosteroids between the distal interphalangeal joint and navicular bursa in horses. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Treatment of finger joints with local steroids. A double-blind study. [2019]

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

Intra-articular injection of methylprednisolone for reducing pain in knee osteoarthritis: A systematic review and meta-analysis. [2021]

6. England 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. [2018]

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

Ketorolac tromethamine - routes and clinical implications. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Ultrasound guided intra-articular ketorolac versus corticosteroid injection in osteoarthritis of the hip: a retrospective comparative study. [2018]

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

Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Minimising the adverse effects of ketorolac. [2018]

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

Evaluating short-term pain after steroid injection. [2013]

12. England pubmed.ncbi.nlm.nih.gov

Methylprednisolone versus triamcinolone in painful shoulder using ultrasound-guided injection. [2016]

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

Intra-articular corticosteroids. An updated assessment. [2006]