NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
- Registration Number
- NCT05992883
- Lead Sponsor
- Mayo Clinic
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-steroidal anti-inflammatory drug (NSAID) Ketorolac 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). Corticosteroid Triamcinolone 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).
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method Michigan Hand Outcomes Questionnaire (MHQ) 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.
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.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States