NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Triamcinolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-steroidal anti-inflammatory drug (NSAID)<br>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<br>* Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).<br>* Other names: Toradol;|
| Active Comparator: Corticosteroid<br>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<br>* Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Steroid, NSAID, Injection, Thumb Arthritis, CMC Arthritis