Recruiting
Phase 3

Ketorolac vs. Triamcinolone

Sponsor:

Mayo Clinic

Code:

NCT05992883

Conditions

Thumb Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Triamcinolone

Study Details

Brief summary:

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).

Conditions

Thumb Osteoarthritis

Study ID

NCT05992883

Start date

Jul 28, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-steroidal anti-inflammatory drug (NSAID)

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).

active comparator: Corticosteroid

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).

Interventions

Ketorolac

Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).

Triamcinolone

Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).

Primary outcome measure

  • Visual Analogue Scale (VAS) of Pain [ Time Frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection. ]

Central Contacts and Locations

Central contacts

Lindsey Hobbs

5072939765hobbs.lindsey@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lindsey Hobbs

15072262669hobbs.lindsey@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Injection
  • Steroid
  • NSAID
  • Thumb Arthritis
  • CMC Arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-23.