NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05992883

Collaborator

(none)

240

Enrollment

Location

Arms

16.2

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Thumb Osteoarthritis	Drug: Ketorolac Drug: Triamcinolone	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Care Provider)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Michigan Hand Outcomes Questionnaire (MHQ) [At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.]
Patient-reported MHQ score
Grip Strength [At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.]
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.
Apposition Strength [At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.]
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.
Opposition Strength [At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.