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Corticosteroid

Betamethasone vs Ketorolac Injection for De Quervain's Tenosynovitis

Phase 4
Waitlist Available
Led By Christopher Chadderdon, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of DeQuervain tendinopathy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection
Awards & highlights

Study Summary

This trial will compare the effects of a corticosteroid injection versus a toradol injection for treating de Quervain tendinopathy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or infection, potential elevation of blood sugars especially in diabetics, allergic reactions including rash or breathing difficulties, and general side effects from steroids such as mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with DeQuervain's tendinopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual analog scale (VAS) of pain with finklestein test
Secondary outcome measures
Grip Strength
Pinch Strength
The Disabilities of the Arm, Shoulder, and Hand Score (DASH)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KetorolacExperimental Treatment1 Intervention
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)
Group II: BetamethasoneActive Control1 Intervention
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760

Find a Location

Who is running the clinical trial?

OrthoCarolina Research Institute, Inc.Lead Sponsor
34 Previous Clinical Trials
5,867 Total Patients Enrolled
Christopher Chadderdon, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.

Media Library

Betamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02604537 — Phase 4
De Quervain's Tenosynovitis Research Study Groups: Ketorolac, Betamethasone
De Quervain's Tenosynovitis Clinical Trial 2023: Betamethasone Highlights & Side Effects. Trial Name: NCT02604537 — Phase 4
Betamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02604537 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Ketorolac been tested in other medical experiments?

"Currently, there are 52 clinical trials for Ketorolac with 12 of those in Phase 3. A vast majority are conducted out of Los Angeles, California; though many other cities across the country also run these studies."

Answered by AI

What medical maladies is Ketorolac commonly deployed to address?

"Ketorolac has a multitude of clinical applications, from the treatment of myopia to managing symptoms associated with multiple sclerosis and ulcerative colitis."

Answered by AI

What is the current number of participants engaged in this experiment?

"Unfortunately, this particular study is no longer recruiting patients. It was first posted on October 15th 2015 and modified most recently on August 16th 2022. Presently, there are 80 trials enrolling individuals with tenosynovitis and 52 studies welcoming participants for Ketorolac research."

Answered by AI

Are there still opportunities to enroll in this experiment?

"Unfortunately, this study has closed and is no longer recruiting patients. It was initially announced on October 15th 2015 with the last update taking place August 16th 2022. For those seeking clinical trials for tenosynovitis, there are currently 80 research studies open; likewise there are 52 Ketorolac trials still enrolling participants."

Answered by AI

Is there any precedent for this research venture?

"Since 2010, ketorolac has been subject to numerous clinical trials. The initial trial was sponsored by Mantecorp Industria Quimica e Farmaceutica Ltd., and included 170 participants. Subsequently, the drug received Phase 3 approval from regulatory agencies. Currently, 52 studies are ongoing across 79 cities in 27 nations worldwide."

Answered by AI

Has the FDA sanctioned Ketorolac for patient use?

"As this is a Phase 4 trial for Ketorolac, meaning the drug has been approved in the past, our team at Power believes its safety to be unquestionable and thus gave it a score of 3."

Answered by AI
~5 spots leftby Dec 2024