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

Trial Summary

What is the purpose of this trial?

The Researchers are trying to compare two different types of intraarticular injections (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a corticosteroid).

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.

What data supports the effectiveness of the drug triamcinolone for thumb arthritis?

Research shows that triamcinolone injections can significantly reduce pain and improve hand function in patients with joint osteoarthritis, including the thumb. In a study comparing triamcinolone to another treatment, it was found to be more effective in reducing pain and improving hand function over a 12-month period. ^{1 2 3 4 5}

Is it safe to use NSAID or corticosteroid injections for thumb arthritis?

Research shows that both ketorolac (an NSAID) and triamcinolone (a corticosteroid) have been used safely in humans for conditions like shoulder impingement and trigger digits. However, the specific safety for thumb arthritis isn't detailed, but these treatments are generally considered safe for similar joint issues. ^{1 2 3 6 7}

How does the drug used in the trial for thumb arthritis differ from other treatments?

The trial compares ketorolac, a non-steroidal anti-inflammatory drug (NSAID), and triamcinolone, a corticosteroid, for thumb arthritis. Ketorolac is typically used for short-term pain relief, while triamcinolone is known for its anti-inflammatory effects and longer-lasting pain relief, making it potentially more effective for reducing symptoms over time. ^{1 2 3 7 8}

Research Team

Marco Rizzo, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

My pain did not improve with painkillers, anti-inflammatories, ice, or splints.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing ketorolac and triamcinolone injections in adults with trigger digits. [2020]

3. United States 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. [2022]

4. Singapore pubmed.ncbi.nlm.nih.gov

Different Dosages of Triamcinolone Acetonide Injection for the Treatment of Trigger Finger and Thumb: A Randomized Controlled Trial. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Comparison of therapeutic effects of sodium hyaluronate and corticosteroid injections on trapeziometacarpal joint osteoarthritis. [2022]

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

The safety of intraocular ketorolac in rabbits. [2022]

7. Canada 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. [2017]

8. France 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. [2021]