Betamethasone vs Ketorolac Injection for De Quervain's Tenosynovitis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: NSAIDs, ASA

Disqualifiers: Allergies, Prior steroid injection, 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: 5

Duration: 1 day

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.

Who Is on the Research Team?

Christopher Chadderdon, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals who can understand and follow the study protocol, have signed consent forms, and are diagnosed with DeQuervain tendinopathy. It's not for those allergic to lidocaine, celestone, or ketorolac; have skin issues at the injection site; had a steroid injection in the last 3 months; have an infection at the injection site; previous surgery for this condition; are breastfeeding or pregnant.

Inclusion Criteria

I have been diagnosed with DeQuervain's tendinopathy.

Understands the local language and is willing and able to follow the requirements of the protocol

Understands the informed consent and signs the institutional review board/independent ethics committee (IRB/IEC) approved informed consent form

Exclusion Criteria

Patients who have an allergy to lidocaine, celestone, or ketorolac, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (ASA)

I've had severe reactions to lidocaine, celestone, or ketorolac.

I have received a steroid injection in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a ketorolac or betamethasone injection for the treatment of DeQuervain's tenosynovitis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

4 visits (in-person) at 2 weeks, 6 weeks, 3 months, and 6 months post-injection

What Are the Treatments Tested in This Trial?

Interventions

• Betamethasone
• Ketorolac

Trial Overview The study aims to compare two treatments: betamethasone (a corticosteroid) and ketorolac (a pain reliever) injections for DeQuervain's tenosynovitis. The goal is to see if one modifies the disease course more effectively than the other.

How Is the Trial Designed?

Group I: Ketorolac Experimental Treatment 1 Intervention

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)

Group II: Betamethasone Active Control 1 Intervention

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+