NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

NCT05992883 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 22-005275
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Injection; Steroid; NSAID; Thumb Arthritis; CMC Arthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) of Pain

  Patient-reported VAS score with both motion and rest of the CMC joint. The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain.

  At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

Secondary Outcomes (4)

• Michigan Hand Outcomes Questionnaire (MHQ)

  At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

• Grip Strength

  At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

• Apposition Strength

  At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

• Opposition Strength

  At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

Study Arms (2)

Non-steroidal anti-inflammatory drug (NSAID)

EXPERIMENTAL

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).

Drug: Ketorolac

Corticosteroid

ACTIVE COMPARATOR

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).

Drug: Triamcinolone

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Non-steroidal anti-inflammatory drug (NSAID)

Triamcinolone DRUG

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

Corticosteroid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to either of the treatment products
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ketorolac; Ketorolac Tromethamine; Triamcinolone

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marco Rizzo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Hobbs

CONTACT

5072939765; hobbs.lindsey@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: After enrollment and completion of the initial clinical evaluation, patients will undergo the injection procedure while blinded to the medication they receive. The injecting physician will also be blinded to the medication being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This trial will be a single center, comparative, randomized (1:1 ratio), prospective, double-blind trial with two groups evaluated concurrently. One group will be given triamcinolone injections while the second, experimental group will receive ketorolac injections.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)