No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for adults over 40 with thumb arthritis pain that hasn't improved with usual treatments. Participants will receive one of two types of injections to help relieve their symptoms.
Are You a Good Fit for This Trial?
Rules you outInflammatory arthritisSevere hypertensionDe Quervain tendinopathyImmunodeficiency
You may be able to join if
I am over 40 years old
I have pain at the base of my thumb from pressure and movement
I have tried other treatments that didn't work
I have been diagnosed with thumb arthritis based on imaging
I understand the study and can give my consent
I have health insurance
You may not be able to join if
I am allergic to either treatment
I have changed my pain management plan in the last 4 weeks
I have another type of arthritis affecting my wrist
I have an infection
I have had surgery on my thumb
I have had an injury to my thumb
I have uncontrolled diabetes
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The Researchers are trying to compare two different types of intraarticular injections (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a corticosteroid).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Adults \>40 years of age
* Pain at the thumb base brought on by direct pressure (grind test) and with movement
* Pain resistant to previous conservative management (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics…
Inclusion Criteria:
* Adults \>40 years of age
* Pain at the thumb base brought on by direct pressure (grind test) and with movement
* Pain resistant to previous conservative management (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
* Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
* Patient understands the protocol and signed the informed consent
* Patient is covered by health insurance
Exclusion Criteria:
* • Known allergy to either of the treatment products
* Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
* Symptomatic Scaphoid-trapezial arthritis present
* Localized or systemic infection
* Previous thumb surgery on study thumb
* Previous thumb injury on study thumb
* Patient with inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
* Severe and/or uncontrolled hypertension
* De Quervain tendinopathy present
* History of injection to the trapeziometacarpal joint on study thumb within the previous 6 weeks
* Uncontrolled diabetes
* Pregnant or lactating females. Female participants of childbearing potential must have a negative pregnancy test before the injection. Women without childbearing potential (ie., surgically sterile with hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without completing a pregnancy test.
* Immunodeficient patients
* Patients that are currently using nicotine products, or who have quit in the last 12 months
* Patients under guardianship, curatorship, or are otherwise not self-sufficient
* Patients participating in another clinical research trial which interferes with this study protocol or outcomes
* Patients unable to follow the protocol in the investigators' judgement.
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