Ketorolac vs Triamcinolone Injections for Tendinopathy or Arthritis

Recruiting at 3 trial locations

Overseen By Paul A. Ghareeb, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Under 18, Prior surgery, Infection, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of injections, ketorolac (a nonsteroidal anti-inflammatory drug) and triamcinolone (a corticosteroid), to determine which is more effective for easing pain and improving movement in tendons and joints of the shoulder, elbow, hand, and wrist. While these injections are already used to manage pain in larger joints, such as knees, this study focuses on smaller joints and tendons. Participants will receive one of these treatments without knowing which one, ensuring unbiased results. Suitable candidates for the trial are adults with ongoing shoulder, elbow, hand, or wrist pain from conditions like trigger finger or wrist arthritis who have not undergone surgery for these issues. As a Phase 4 trial, this research aims to understand how these FDA-approved treatments can benefit more patients.

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 is the safety track record for these treatments?

Research shows that both ketorolac and triamcinolone injections effectively manage pain, but each has specific safety considerations.

Studies indicate that ketorolac provides significant pain relief, but important safety factors must be considered. It should not be used for more than five days due to risks of heart issues, kidney problems, and stomach ulcers. Serious side effects may include vomiting blood, black stools, and severe stomach pain.

Triamcinolone, a type of steroid, helps reduce swelling and redness. It is generally well-tolerated, but side effects can include a higher risk of infections, mood changes, or increased blood sugar levels. Following a doctor's instructions is crucial to minimize these risks.

Both treatments have undergone thorough study and are generally considered safe when used carefully and under a doctor's supervision. Discussing concerns with a healthcare provider can help ensure the treatment is appropriate. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because ketorolac and triamcinolone offer potential advantages for managing tendinopathy or arthritis. Unlike many standard treatments that rely heavily on long-term pain relief through oral medications, ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that provides targeted, quick-acting pain relief directly at the injection site. Triamcinolone, on the other hand, is a corticosteroid that reduces inflammation and pain with potentially longer-lasting effects. These injections could offer faster pain relief and more localized treatment compared to traditional oral medications, which might take longer to show effectiveness and can affect the entire body.

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

This trial will compare the effectiveness of ketorolac and triamcinolone injections for tendinopathy or arthritis. Research has shown that both injections can effectively reduce pain and improve movement in joint and tendon issues. Participants in this trial may receive ketorolac, which studies have found to relieve pain as effectively as corticosteroids like triamcinolone. Ketorolac is considered safe and effective, offering similar benefits to corticosteroids without significant cost differences. Participants receiving triamcinolone injections may experience significant pain relief, although the effects may not last as long. Both treatments are well-established options for managing pain in conditions such as osteoarthritis and tendinopathy. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul A. Ghareeb, MD

Principal Investigator

Emory University

Amanda L Dempsey

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 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.

I have hand or wrist joint pain without previous surgery for it.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac
• Triamcinolone

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.

How Is the Trial Designed?

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 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?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

American Association for Hand Surgery: AAHS

Collaborator

Trials

1

Recruited

160+

American Association for Hand Surgery

Collaborator

Trials

1

Recruited

160+

Published Research Related to This Trial

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 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 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 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 rat Achilles tendons, the addition of platelet-rich plasma (PRP) to triamcinolone acetonide (TA) injections significantly prevented the negative effects of TA, such as reduced tendon strength and stiffness, which were observed in the TA-only group.

Histological analysis showed that PRP administration prevented harmful changes in tendon structure caused by TA, suggesting that PRP could serve as a protective agent for patients receiving corticosteroid injections for sports injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Platelet-Rich Plasma Protect Rat Achilles Tendons From the Deleterious Effects of Triamcinolone Acetonide? Muto, T., Kokubu, T., Mifune, Y., et al.[2022]

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]

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 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]

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

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Effect of Intra-articular Ketorolac Versus Corticosteroid ... Conclusion: 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 The authors did not find any difference in pain relief between the groups at 1, 3, or 6 months, suggesting that ketorolac and corticosteroid intraarticular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05292339

Ketorolac in Upper Extremity Tendinopathy and Arthropathy The literature demonstrates that intra-articular NSAID injections are effective in reducing pain and functional disability in patients with knee and hip OA, ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/541215

Ketorolac in Upper Extremity Tendinopathy and Arthropathy The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, wrist, and hand tendinopathy or ...

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

Economic Impact of Ketorolac vs Corticosteroid Intra ... Ketorolac knee injection is safe and effective with a cost savings percentage difference of 143% when compared with corticosteroid.

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Ketorolac (oral route, injection route) - Side effects & dosage Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with ...

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

Ketorolac (Toradol) – Uses, Side Effects, and More What are the serious side effects of ketorolac? · Vomit blood · Black or tarry poop · Stomach pain that does not go away · Upset stomach · Feel faint.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545172/

Ketorolac - StatPearls - NCBI Bookshelf Ketorolac administration should not continue for longer than 5 days, given an increased risk of cardiac thrombotic events, renal failure, peptic ulcers, and ...

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Ketorolac Tromethamine Injection, USP SAFETY DATA SHEET. Product Name: Ketorolac Tromethamine Injection ... Clinically, this product is used for the management of pain. In ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/019645s019lbl.pdf

TORADOL (ketorolac tromethamine tablets) Rx only ... This parameter was determined from single- dose data. The ketorolac tromethamine racemate has been shown to be highly protein bound (99%). Nevertheless, plasma ...