NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
Recruiting · NCT05992883 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
KetorolacTriamcinolone
What this trial is about
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).
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Mayo Clinic - Rochester, Minnesota, United States