Ketorolac vs Triamcinolone Injections for Tendinopathy or Arthritis

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Amanda L Dempsey

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Emory University

Disqualifiers: Under 18, Prior surgery, Infection, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing two types of injections, ketorolac and triamcinolone, to help patients with painful conditions in their shoulder, elbow, wrist, and hand. These injections aim to reduce inflammation and pain, improving movement and function. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) known for its potent nonopioid pain-relieving activity, effective in treating moderate to severe pain, especially after surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 Triamcinolone for tendinopathy or arthritis?

Research shows that triamcinolone injections can be more effective than ketorolac in relieving symptoms of trigger digits, a condition similar to tendinopathy, especially in the short term. However, ketorolac and triamcinolone had similar long-term outcomes in terms of symptom resolution. ^{1 2 3 4 5}

Is it safe to use Ketorolac and Triamcinolone injections in humans?

Triamcinolone injections are commonly used for various conditions, but they can have harmful effects like tendon damage. Ketorolac has been tested for safety in animals, but specific human safety data is limited. ^{4 5 6 7 8}

How do ketorolac and triamcinolone injections differ from other drugs for tendinopathy or arthritis?

Ketorolac and triamcinolone injections are unique because they offer different mechanisms of action: ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation, while triamcinolone is a corticosteroid that provides longer-lasting anti-inflammatory effects. This combination provides a novel approach by potentially offering both immediate and sustained relief for tendinopathy or arthritis. ^{1 4 5 7 9}

Research Team

Paul A. Ghareeb, MD

Principal Investigator

Emory University

Amanda L Dempsey

Principal Investigator

Emory University

Eligibility Criteria

Adults with painful conditions of the hand or wrist, like trigger finger, De Quervain's tenosynovitis, or osteoarthritis in certain joints. They shouldn't have had surgery for these issues before. People under 18, those who've had similar injections recently, with allergies to the drugs used, or an active infection at the injection site can't join.

Inclusion Criteria

I am 18 years old or older.

I have a diagnosis of a hand or wrist condition, such as trigger finger or arthritis in specific joints.

I have been diagnosed with a specific hand or wrist joint condition.

Exclusion Criteria

I am under 18 years old.

I have not had triamcinolone or ketorolac injections in the last 6 months.

I have had surgery for my hand condition before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ketorolac or triamcinolone injections for tendinopathy or arthropathy in the shoulder, elbow, wrist, or hand

6 weeks

1 visit (in-person) for injection

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of pain, grip strength, and hand function

18 weeks

2 visits (in-person) at 6 weeks and 24 weeks

Treatment Details

Interventions

• Ketorolac (Nonsteroidal Anti-inflammatory Drug)
• Triamcinolone (Corticosteroid)

Trial Overview The trial is testing if Ketorolac or Triamcinolone injections help reduce pain and improve function in patients with tendinopathy or arthropathy of the shoulder, elbow, wrist, and hand. Participants won't know which treatment they get and will be followed up after 6 weeks.

Participant Groups

Group I: Triamcinolone injection to the shoulder, elbow, wrist, or hand Active Control 1 Intervention

Participants will receive the triamcinolone injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Group II: Ketorolac injection to the shoulder, elbow, wrist, or hand Active Control 1 Intervention

Participants will receive the Ketoralac injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Ketorolac is already approved in Switzerland for the following indications:

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

American Association for Hand Surgery: AAHS

Collaborator

Trials

1

Recruited

160+

American Association for Hand Surgery

Collaborator

Trials

1

Recruited

160+

Findings from Research

A low dose of 0.1 mg/mL of triamcinolone acetonide (TA) caused temporary changes in cell morphology and increased apoptosis in rotator cuff-derived cells, but these effects were reversible by 21 days.

In contrast, a high dose of 1.0 mg/mL of TA resulted in irreversible damage to cell morphology and viability, indicating that higher doses are unsafe for treating tendinopathy, and a re-administration interval of more than three weeks is necessary to avoid adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose- and time-dependent effects of triamcinolone acetonide on human rotator cuff-derived cells. Harada, Y., Kokubu, T., Mifune, Y., et al.[2022]

In a study involving 57 participants with chronic rotator cuff tendinopathy, both subcutaneous 5% dextrose and corticosteroid injections significantly reduced pain, with dextrose showing a nearly significant advantage in pain reduction one month after treatment.

The 5% dextrose treatment was found to be at least as effective as corticosteroids for pain relief, and importantly, no serious adverse effects were reported in either treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial corticosteroid injection versus subcutaneous 5% dextrose in patients with chronic rotator cuff tendinopathy: A short-term randomized clinical trial. Amanollahi, A., Asheghan, M., Hashemi, SE.[2022]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

In a study of 31 eyes from 30 patients, subconjunctival injections of triamcinolone acetonide significantly improved visual acuity and reduced central macular thickness over 12 months, indicating its efficacy in treating uveitic macular edema.

The treatment was found to be safe, with no significant increase in intraocular pressure and only one cataract diagnosed, which occurred in an uninjected eye, suggesting minimal risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. Bleriot, A., Couret, C., Le Meur, G., et al.[2014]

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. England pubmed.ncbi.nlm.nih.gov

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

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

Dose- and time-dependent effects of triamcinolone acetonide on human rotator cuff-derived cells. [2022]

3. Hungary pubmed.ncbi.nlm.nih.gov

Subacromial corticosteroid injection versus subcutaneous 5% dextrose in patients with chronic rotator cuff tendinopathy: A short-term randomized clinical trial. [2022]

4. 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]

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

Can Platelet-Rich Plasma Protect Rat Achilles Tendons From the Deleterious Effects of Triamcinolone Acetonide? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

7. France pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subconjunctival triamcinolone injections in the management of uveitic macular edema: retrospective study of thirty-one cases]. [2014]

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

The safety of intraocular ketorolac in rabbits. [2022]

9. 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]