NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Drug: Ketorolac; Drug: Triamcinolone

Detailed Description

Cartilage degeneration resulting in osteoarthritis is the most common and costly musculoskeletal disorder in the United States, with basilar thumb arthritis being one of the most common manifestations of this disease. Despite its prevalence and previous research on treatments for the disease, there is a dearth of efficacious and low-cost interventions for trapeziometacarpal arthritis. Of these nonoperative interventions, intraarticular corticosteroid injections are the most popular and have the most evidence indicating their benefit. However, long-term use of corticosteroids has a well-established degenerative effect that is counterproductive to preserving cartilage and bone of the CMC joint. Novel, disease-modifying osteoarthritis treatments such as platelet rich plasma and human recombinant bone morphogenic protein 7, among others, are alternative options for patients. Many of these are currently in advanced development, but to date none have achieved FDA approval, and all are significantly more expensive and have limited availability compared to intraarticular corticosteroids.

Although used infrequently, non-steroidal anti-inflammatory drugs (NSAIDs) are another modality of nonoperative intervention for basilar thumb arthritis. Intraarticular injections of NSAIDs have demonstrated success in alleviating the symptoms of primary arthritis in the hip and knee without concern of systemic side effects compared to oral NSAID use. Additionally, injectable NSAIDs are significantly more cost-effective compared to other injectables and do not have the chondrotoxic profile of corticosteroids. However, there are few studies directly comparing intraarticular NSAID use to other injectable therapies.

Given the potential clinical and economic benefits of injectable NSAID therapy, we propose a clinical trial investigation examining the efficacy of intraarticular ketorolac versus intraarticular triamcinolone in treating symptoms of moderate to advanced primary osteoarthritis of the basilar thumb. The prospect of successfully alleviating symptoms of joint degeneration without propagating the progression of disease would be invaluable to the thousands of patients in the Mayo Clinic system and elsewhere afflicted with basilar thumb arthritis without the means or ability to pursue stem cell therapeutics or more definitive, operative intervention.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lindsey Hobbs; Phone Number: 15072262669; Email: hobbs.lindsey@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Lindsey Hobbs; Phone Number: 507-226-2669; Email: hobbs.lindsey@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 with oral analgesics, NSAIDs, icing, and splinting
• Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
• Patient could understand the protocol and signed the informed consent
• Patient was covered by health insurance

Exclusion Criteria:

• Known allergy to either of the treatment products
• Patient's analgesic treatment regimen was modified within four weeks before trial inclusion
• 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
• Previous injections to the trapeziometacarpal joint on study thumb
• Uncontrolled diabetes
• Pregnant or lactating females
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Ketorolac; Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).; Other Names: Toradol
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).	Drug: Triamcinolone; Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) of Pain	Patient-reported VAS score with both motion and rest of the CMC joint.	At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Outcomes Questionnaire (MHQ)	Patient-reported MHQ score	At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Grip Strength	Grip strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.	At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Apposition Strength	Apposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.	At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Opposition Strength	Opposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.	At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Marco Rizzo, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Steroid; NSAID; Injection; Thumb Arthritis; CMC Arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Ketorolac; Triamcinolone
• Other Study ID Numbers: 22-005275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes