Thumb OsteoarthritisPhase 3NCT05992883
NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
A Phase 3 study testing Ketorolac and Triamcinolone in people with Thumb Osteoarthritis, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Ketorolac and Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
- Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
- Patient understands the protocol and signed the informed consent
- Patient is covered by health insurance
Who cannot join
- • Known allergy to either of the treatment products
- Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
- Symptomatic Scaphoid-trapezial arthritis present
- Localized or systemic infection
- Previous thumb surgery on study thumb
- Previous thumb injury on study thumb
Show all 17Show fewer
- Patient with inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
- Severe and/or uncontrolled hypertension
- De Quervain tendinopathy present
- History of injection to the trapeziometacarpal joint on study thumb within the previous 6 weeks
- Uncontrolled diabetes
- Pregnant or lactating females. Female participants of childbearing potential must have a negative pregnancy test before the injection. Women without childbearing potential (ie., surgically sterile with hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without completing a pregnancy test.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lindsey Hobbs, 15072262669, hobbs.lindsey@mayo.edu
About this study
Official title: NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial
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).
Read the 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.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Ketorolac, Triamcinolone
- Keywords
- Injection, Steroid, NSAID, Thumb Arthritis, CMC Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
TriamcinoloneDrug
Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
| Study group | Role | What they receive |
|---|---|---|
| Non-steroidal anti-inflammatory drug (NSAID) | Experimental | 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). Receives: Drug: Ketorolac |
| Corticosteroid | Active comparator | 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). Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) of Pain
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.
Measured: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Secondary outcomes (4)
Michigan Hand Outcomes Questionnaire (MHQ)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start28 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Rizzo, Mayo Clinic
- Investigators
- Marco Rizzo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992883
- Sponsor's protocol ID
- 22-005275
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05992883
- Acronym / sponsor ID
- 22-005275
- Conditions
- Thumb Osteoarthritis
- Keywords
- Injection, Steroid, NSAID, Thumb Arthritis, CMC Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-steroidal anti-inflammatory drug (NSAID) | Experimental | Drug: KetorolacPatients 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 | Active comparator | Drug: TriamcinolonePatients 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
- Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
- Patient understands the protocol and signed the informed consent
Key exclusion criteria (17 listed)
- • Known allergy to either of the treatment products
- Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
- Symptomatic Scaphoid-trapezial arthritis present
- Localized or systemic infection
- Previous thumb surgery on study thumb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: ToradolIntervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac). | Drug | Non-steroidal anti-inflammatory drug (NSAID) |
| TriamcinoloneIntervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone). | Drug | Corticosteroid |
Primary outcome
Visual Analogue Scale (VAS) of Pain
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.
4 secondary outcomes
Michigan Hand Outcomes Questionnaire (MHQ)
Time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Grip Strength
Time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Apposition Strength
Time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Opposition Strength
Time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
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Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Rizzo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac and Triamcinolone in people with Thumb Osteoarthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Hobbs (5072939765, hobbs.lindsey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) of Pain (time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.