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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of injections to determine which is more effective for de Quervain's tendinopathy, a condition causing pain on the thumb side of the wrist. The goal is to assess whether a corticosteroid injection alters the condition's progression compared to a toradol injection. Participants will receive either a betamethasone (a type of steroid) or a ketorolac (a pain reliever) injection. This trial may suit individuals diagnosed with de Quervain's tendinopathy who can meet the study requirements. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify if 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 has shown that both betamethasone and ketorolac treat de Quervain's tenosynovitis, but with varying results. Betamethasone, a steroid, successfully reduces pain and improves movement for many. Some studies report it lowers pain levels and leads to better outcomes in about 73% of cases, though it may cause side effects like increased blood sugar levels.

Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), also relieves pain but may not be as effective as betamethasone in reducing pain and improving movement. It is generally well-tolerated, but like other NSAIDs, it can cause mild side effects such as stomach upset.

Both treatments have shown some success, but betamethasone appears to provide more relief for many individuals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer potentially more effective options for De Quervain's Tenosynovitis, a condition typically managed with corticosteroid injections like triamcinolone. Betamethasone, a potent corticosteroid, is used here and might provide longer-lasting relief due to its strong anti-inflammatory properties. On the other hand, Ketorolac is an NSAID that works differently by blocking pain and inflammation pathways, offering an alternative for patients who may not tolerate steroids well. These treatments could provide quicker pain relief or more sustained symptom management compared to traditional options.

What evidence suggests that this trial's treatments could be effective for de Quervain's tenosynovitis?

This trial will compare the effectiveness of Betamethasone and Ketorolac injections for treating de Quervain's tenosynovitis. Research has shown that corticosteroid injections, such as Betamethasone, work well for this condition. In one study, 73.4% of patients experienced successful treatment after receiving a corticosteroid injection. Specifically, patients who received Betamethasone reported less pain and better results compared to other treatments. Studies indicate that Ketorolac, another treatment option in this trial, is not as effective as corticosteroids like Betamethasone in reducing pain and improving function. Overall, Betamethasone is considered a more effective choice for managing symptoms of de Quervain's tenosynovitis. ^{1 2 3 5 6}

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

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

I have been diagnosed with DeQuervain's tendinopathy.

Exclusion Criteria

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

Patients who are breast feeding, pregnant, or who plan to become pregnant in the next six months

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

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5484456/

Effectiveness of Corticosteroid Injections for Treatment ...

Conclusions: This study indicates that corticosteroid injections are a useful treatment for de Quervain's tenosynovitis, leading to treatment success 73.4% of ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4655850/

The Effectiveness of Corticosteroid Injection for De Quervain's ...

This review confirms that corticosteroid injection results in an increase in the resolution of symptoms, increased pain relief and increase in function

3.

jhandsurg.org

jhandsurg.org/article/S0363-5023(17)31086-9/fulltext

Betamethasone Versus Ketorolac Injection for the ...

Patients randomized to betamethasone injection had significantly lower pain scores and better patient-recorded outcomes at six weeks compared to patients ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0363502324000996

Advancements in de Quervain Tenosynovitis Management

Conclusions. Corticosteroid injection with a short duration of immobilization remains the primary and effective treatment for de Quervain tenosynovitis.

5.

mdpi.com

mdpi.com/2075-4426/14/9/928

De Quervain Tendinopathy: Anatomical Prognostic ...

When reporting the results of a single corticosteroid injection, Zingas et al. had a 58% success rate in 19 wrists after three months of follow- ...

6.

rapm.bmj.com

rapm.bmj.com/content/early/2025/02/26/rapm-2024-105656

Use and safety of corticosteroid injections in joints and ...

Overall, IACS injections result in short-term pain relief from a few weeks to a few months. The adverse events include an increase in blood ...