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Nonsteroidal Anti-inflammatory Drug
NSAID vs Corticosteroid Injections for Thumb Arthritis
Phase 3
Recruiting
Led By Marco Rizzo, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Awards & highlights
Study Summary
This trial will compare two treatments for basilar thumb arthritis: ketorolac and triamcinolone injections.
Who is the study for?
This trial is for adults over 40 with moderate to advanced basilar thumb arthritis, who've had pain despite using oral painkillers, NSAIDs, icing, and splinting. They must have X-ray evidence of arthritis and health insurance. Excluded are those allergic to the treatments, with inflammatory arthritis or certain other conditions, pregnant or breastfeeding women, recent nicotine users, and those unable to follow the protocol.Check my eligibility
What is being tested?
Researchers are comparing two injections for thumb arthritis: Ketorolac (an NSAID) versus Triamcinolone (a corticosteroid). The goal is to see which one better eases symptoms in patients who haven't responded well to other conservative treatments.See study design
What are the potential side effects?
Ketorolac may cause injection site reactions, stomach issues or increase bleeding risk. Triamcinolone could lead to joint infection risks, increased blood sugar levels in diabetics or temporary flare-ups of joint pain after the injection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analogue Scale (VAS) of Pain
Secondary outcome measures
Apposition Strength
Grip Strength
Michigan Hand Outcomes Questionnaire (MHQ)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-steroidal anti-inflammatory drug (NSAID)Experimental Treatment1 Intervention
Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
Group II: CorticosteroidActive Control1 Intervention
Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
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?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,248 Total Patients Enrolled
29 Trials studying Osteoarthritis
2,850 Patients Enrolled for Osteoarthritis
Marco Rizzo, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an infection that is either in one place or all over my body.I have been diagnosed with De Quervain's tendinopathy.I experience pain at the base of my thumb when pressed or moved.My high blood pressure is severe or not well-controlled.My pain medication was changed less than 4 weeks ago.My pain did not improve with painkillers, anti-inflammatories, ice, or splints.My diabetes is not under control.I have had surgery on my thumb that is being studied.I have a type of inflammatory arthritis.I have arthritis in my wrist.I have had injections in my thumb joint for this study.I am not under legal guardianship and can make my own decisions.I am over 40 years old.I have a weakened immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Non-steroidal anti-inflammatory drug (NSAID)
- Group 2: Corticosteroid
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the U.S. Food and Drug Administration endorsed usage of Non-steroidal anti-inflammatory drug (NSAID)?
"The risk assessment of Non-steroidal anti-inflammatory drug (NSAID) is rated by our team at Power as 3, signifying that the Phase 3 trial has generated supportive evidence for efficacy and consistent results from multiple safety tests."
Answered by AI
Are there currently any openings for participants in this investigation?
"Affirmative. Clinicaltrials.gov data reveals that this clinical trial, which was first advertised on July 28th 2023, is still recruiting patients. A total of 240 participants must be enrolled from 1 medical facility."
Answered by AI
How many individuals are partaking in this research endeavor?
"Affirmative. Per the information on clinicaltrials.gov, this experimental study is actively seeking participants since it was first posted on July 28th 2023 and updated most recently on August 7th 2023. More precisely, 240 patients must be enrolled from 1 medical centre."
Answered by AI
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