Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT05992883
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).
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Phase 3
Rochester, Minnesota, 55905, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
Other names: Toradol
Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
Time frame: 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. 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.
Time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
The Michigan Hand Outcomes Questionnaire (MHQ) is patient-reported. An overall MHQ score can be obtained by summing the scores for all six scales after reversing the pain scale (pain=100-pain score) and then dividing by six. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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