NSAID vs Corticosteroid Injections for Thumb Arthritis

Overseen By Lindsey Hobbs

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Disqualifiers: Inflammatory arthritis, Uncontrolled diabetes, Nicotine use, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of injections to alleviate pain from moderate to advanced thumb arthritis. Researchers aim to determine if the non-steroidal anti-inflammatory drug (NSAID) ketorolac is as effective as the corticosteroid triamcinolone. The goal is to identify which injection better relieves pain and enhances movement. Individuals with thumb pain unresponsive to usual treatments, such as over-the-counter medications and braces, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your pain management regimen was changed in the last four weeks, you may not be eligible to participate.

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

Research has shown that ketorolac, a type of pain reliever, is often used after surgery and for conditions like arthritis. It is generally safe for these uses. Some studies suggest it might serve as a good alternative to steroids for joint problems, potentially avoiding some side effects associated with steroids.

Triamcinolone, a steroid, eases joint pain, such as in the knees, due to arthritis. While effective, it carries some risks, including an increased chance of joint damage or infections. Patients should report any unusual symptoms to their doctor.

Both treatments have been used in medical settings, each with its own risks and benefits. Consulting a healthcare professional is essential to determine the most suitable option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for thumb arthritis because they offer new approaches compared to traditional options. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), is being studied for its potential to reduce inflammation and pain without the side effects often associated with long-term steroid use. On the other hand, triamcinolone, a corticosteroid, is already known for its effectiveness in reducing inflammation quickly, but this study could help refine its use or understand its benefits better compared to NSAIDs. These treatments aim to provide more effective pain relief and improved joint function, which could mean quicker relief for patients.

What evidence suggests that this trial's treatments could be effective for thumb arthritis?

This trial will compare the effectiveness of ketorolac and triamcinolone injections for thumb arthritis. Research has shown that both ketorolac, administered to participants in one arm of this trial, and triamcinolone, given to participants in another arm, can relieve pain in thumb arthritis. Ketorolac, a type of pain reliever known as an NSAID, works quickly, with studies showing noticeable pain relief after 3 and 6 months. Triamcinolone, a steroid, also reduces pain and improves thumb movement, with some studies indicating benefits lasting up to 12 months. However, other research suggests its pain relief might only last a few weeks. Both treatments reduce pain, but ketorolac acts faster, while triamcinolone might provide longer-lasting relief. ^{1 5 6 7 8}

Who Is on the Research Team?

Marco Rizzo, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 40 with moderate to advanced basilar thumb arthritis, who've had pain despite using oral painkillers, NSAIDs, icing, and splinting. They must have X-ray evidence of arthritis and health insurance. Excluded are those allergic to the treatments, with inflammatory arthritis or certain other conditions, pregnant or breastfeeding women, recent nicotine users, and those unable to follow the protocol.

Inclusion Criteria

Patient was covered by health insurance

I experience pain at the base of my thumb when pressed or moved.

Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)

Exclusion Criteria

Patients unable to follow the protocol in the investigators' judgement

I have an infection that is either in one place or all over my body.

I have been diagnosed with De Quervain's tendinopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive an intraarticular injection of either ketorolac or triamcinolone

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

4 visits (in-person) at 1 month, 3 months, 6 months, and 1 year post-injection

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac
• Triamcinolone

Trial Overview Researchers are comparing two injections for thumb arthritis: Ketorolac (an NSAID) versus Triamcinolone (a corticosteroid). The goal is to see which one better eases symptoms in patients who haven't responded well to other conservative treatments.

How Is the Trial Designed?

Group I: Non-steroidal anti-inflammatory drug (NSAID) Experimental Treatment 1 Intervention

Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).

Group II: Corticosteroid Active Control 1 Intervention

Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 121 patients with trigger digits, triamcinolone acetonide injections showed significantly better short-term efficacy compared to ketorolac trometamol, with 54% of patients achieving complete resolution of triggering at 6 weeks versus 0% in the ketorolac group.

While both treatments had similar long-term outcomes at 24 weeks, triamcinolone provided superior pain relief and reduced flexion deformity in the initial weeks, indicating it may be the preferred option for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing ketorolac and triamcinolone injections in adults with trigger digits. Leow, MQH., Hay, ASR., Ng, SL., et al.[2020]

In a study of 93 patients with trigger finger, higher doses of triamcinolone acetonide (20 mg) resulted in a significantly higher success rate in reducing symptoms at 3 and 6 months compared to lower doses (5 mg and 10 mg).

All doses showed improvement in symptoms by 6 weeks, but by 12 months, there were no significant differences in success rates among the different dosages, indicating that while higher doses may be more effective initially, the long-term outcomes are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Dosages of Triamcinolone Acetonide Injection for the Treatment of Trigger Finger and Thumb: A Randomized Controlled Trial. Kosiyatrakul, A., Loketkrawee, W., Luenam, S.[2018]

In a study of 60 osteoarthritis patients receiving intra-articular injections, triamcinolone hexacetonide combined with lidocaine significantly reduced joint swelling and decreased the need for pain relief medication over 48 weeks.

However, the treatment did not show any impact on the radiographic progression of osteoarthritis in the injected joints, indicating that while it helps with symptoms, it does not alter the underlying disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis ‒ A double-blinded randomized controlled trial with a one year follow-up. Paschoal, NOS., Natour, J., Machado, FS., et al.[2022]

In a study of 32 patients with external shoulder impingement syndrome, ketorolac injections led to significantly greater improvements in shoulder function and patient satisfaction compared to triamcinolone injections after 4 weeks.

Both treatments were effective in reducing pain and improving range of motion, but ketorolac showed superior results in the UCLA shoulder rating scale, suggesting it may be a safer alternative to corticosteroids with fewer potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. Min, KS., St Pierre, P., Ryan, PM., et al.[2022]

In a study of 40 women with stage II or III trapeziometacarpal joint osteoarthritis, both steroid and sodium hyaluronate injections were effective in reducing pain and improving grip strength, but the steroid injection was superior in pain reduction and enhancing hand function.

The steroid group experienced significant pain reduction over 12 months, while the sodium hyaluronate group saw improvements over 6 months, indicating that steroid injections may provide longer-lasting relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of therapeutic effects of sodium hyaluronate and corticosteroid injections on trapeziometacarpal joint osteoarthritis. Bahadir, C., Onal, B., Dayan, VY., et al.[2022]

In a study involving 15 rabbits, intraocular injections of preservative-free ketorolac tromethamine showed no significant adverse effects on retinal function or intraocular pressure compared to control eyes, indicating its safety for use.

The drug had a short elimination half-life of 2.3 hours in the vitreous, and no histopathological changes were observed, suggesting that ketorolac could be a viable alternative to steroid injections for treating intraocular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of intraocular ketorolac in rabbits. Margalit, E., Kugler, LJ., Brumm, MV., et al.[2022]

Intraarticular injection of triamcinolone hexacetonide (TH) combined with lidocaine (LD) significantly improved pain during movement and reduced joint swelling in patients with osteoarthritis of the hand interphalangeal joints compared to lidocaine alone, with results observed as early as one week after treatment.

The study involved 60 patients, primarily women with an average age of 60.7 years, and found no significant adverse effects from the treatment, indicating that TH/LD is a safe and effective option for managing symptoms of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. Spolidoro Paschoal, Nde O., Natour, J., Machado, FS., et al.[2017]

In a study involving 52 patients with shoulder impingement syndrome, low-volume corticosteroid injections (4 cc) provided similar pain relief and functional outcomes compared to high-volume injections (10 cc), indicating that less medication can be just as effective.

Both injection methods resulted in significant pain reduction over time, with no statistically significant differences in outcomes, suggesting that low-volume injections may be a safer and more efficient option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Boonard, M., Sumanont, S., Arirachakaran, A., et al.[2021]

Citations

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

Ketorolac Injections for Musculoskeletal Conditions Overall, the study indicates that ketorolac's quick onset of pain relief was a key benefit of adding the medication to an intra-articular injection. Hip and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05992883

NSAID Injection Versus Corticosteroid Injection for Basilar ... The prospect of successfully alleviating symptoms of joint degeneration without propagating the progression of disease would be invaluable to the thousands of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6531173/

Ultrasound-guided intra-articular injection of hyaluronic ... The onset of pain relief was significantly more rapid (at 1 month) after the injection containing HA and ketorolac than after the injection containing HA alone.

4. mayo.edu mayo.edu/research/clinical-trials/cls-20548341

NSAID Injection Versus Corticosteroid Injection for Basilar ... The purpose of this study is to examine the effectivenessof intraarticular ketorolac versus intraarticular triamcinolone in treating symptoms of moderate to ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.637904/full

New Trends in Injection-Based Therapy for Thumb ... Indeed, the Authors reported a statistically significant reduction of VAS pain after 3 and 6 months and a significant improvement of DASH score ...

6. go.drugbank.com go.drugbank.com/drugs/DB00465

Ketorolac: Uses, Interactions, Mechanism of Action Ketorolac is an NSAID used to treat moderate to severe pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders, and headaches.

7. webmd.com webmd.com/drugs/2/drug-3919/ketorolac-oral/details

Ketorolac (Toradol) – Uses, Side Effects, and More Ketorolac is commonly used for moderately severe acute pain that needs strong pain relief, often after surgery.

8. sprix.com sprix.com/clinical-data

SPRIX® | Clinical Data SAFETY DATA. SPRIX® (ketorolac tromethamine) was studied in patients enrolled in two placebo-controlled efficacy studies of acute pain following major surgery.