NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

Thumb Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992883
• Other study ID #: 22-005275
• Status: Recruiting
• Phase: Phase 3
• Start date: July 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Lindsey Hobbs
• Phone: 15072262669
• Email: hobbs.lindsey[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Thumb Osteoarthritis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Mayo Clinic Clinical Trials