What side effects are associated with this type of intervention?

Common treatments for tendinopathy include NSAIDs like Ketorolac and corticosteroids like Triamcinolone. NSAIDs can cause gastrointestinal issues, renal impairment, and cardiovascular risks due to their inhibition of prostaglandin production. Corticosteroids, while effective in reducing inflammation, can lead to tendon weakening, increased risk of tendon rupture, and systemic side effects such as weight gain, osteoporosis, and elevated blood sugar levels.

What other types of research exist?

Promising novel alternatives to Ketorolac and Triamcinolone for tendinopathy patients include nitric oxide donors like NO-paracetamol, which enhance tendon healing, and biologic therapies such as platelet-rich plasma (PRP) and stem cell treatments. Additionally, careful use of cyclooxygenase-2 (COX-2) inhibitors during the remodeling phase of tendon healing may offer benefits.

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Nonsteroidal Anti-inflammatory Drug

Ketorolac vs Triamcinolone Injections for Tendinopathy or Arthritis

Q: What prior FDA approvals exist?

The FDA has approved several NSAIDs and corticosteroids for the treatment of tendinopathy. NSAIDs like Ketorolac work by inhibiting prostaglandin production, which helps reduce pain and inflammation. Corticosteroids such as Triamcinolone are also commonly used; they suppress the immune response and decrease inflammation. These treatments are often administered via injections to provide localized relief. While specific FDA approvals for tendinopathy may not be detailed, these classes of drugs are widely accepted and used in clinical practice for managing tendinopathy symptoms.

Phase 4

Recruiting

Led By Amanda L Dempsey

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Symptomatic tendinopathy or arthropathy of the hand or wrist who have not undergone prior surgical treatment for their condition

Must not have

Patients under the age of 18

Patients who have undergone prior surgical treatment for their hand condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 24 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from Ketorolac might include gastrointestinal problems like ulcers and bleeding; kidney damage; allergic reactions; increased blood pressure. Triamcinolone may cause joint pain increase initially; skin discoloration; weakening of bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have painful tendon or joint issues in my hand or wrist and haven't had surgery for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have had surgery for my hand condition before.

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I am allergic or cannot take triamcinolone or ketorolac injections.

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I do not have an infection at the treatment site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Visual Analog Scale (VAS) pain score

Secondary study objectives

Changes in Grip Strength

Changes in Hand subjectivity value

Changes in Key Pinch

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: Triamcinolone injection to the shoulder, elbow, wrist, or handActive Control1 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 handActive Control1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tendinopathy include NSAIDs like Ketorolac and corticosteroids like Triamcinolone. NSAIDs inhibit the enzyme cyclooxygenase (COX), reducing the production of prostaglandins that cause inflammation and pain. Corticosteroids suppress the immune response and decrease inflammation by inhibiting multiple inflammatory pathways. These mechanisms are crucial for tendinopathy patients as they help manage pain and inflammation, facilitating better participation in physical therapy and improving overall function.

[Should athletic injuries be treated with non-steroidal anti-rheumatic agents (NSAID)? Tenoxicam, piroxicam and placebo in the treatment of acute stress-induced injuries].Effects of nonsteroidal anti-inflammatory drugs on flexor tendon adhesion.Inhibition of tendon cell proliferation and matrix glycosaminoglycan synthesis by non-steroidal anti-inflammatory drugs in vitro.